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A Study Using the Esophageal Sponge to Gather Specimens for Management of Dietary Therapy in Eosinophilic Esophagitis
Rochester, MN
The purpose of this study is to see if the cytosponge ( a 10 minute, in office procedure that does not require sedation) can be used to replace the 6-10 endoscopies that are routinely performed during the standard of care dietary restriction and food reintroduction trials to manage eosinophilic esophagitis.
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A Study Developing a Rapid Count for Total Bacteria in Human Intestinal Fluid
Scottsdale/Phoenix, AZ
The purpose of this study is to develope a rapid lab test for counting total bacteria in human intestinal fluid collected by aspiration from the duodenal section of the small intestine.
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A Study of Nasal Swab Mucus with Metabolomic Analysis
Rochester, MN
The purpose of this study is determine if the metabolomic profile of nasal secretions can be used to reliably diagnose the presence or absence of sinusitis.
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Assessing the Utility of Quantitative Fecal Fat Studies to Diagnose Small Intestinal Bacterial Overgrowth (SIBO)
Rochester, MN
The purpose of this study is to understand how the results from a fecal fat test compare to results from the duodenal aspirate culture which was collected during a recent clinical EGD. The goal is to determine whether this less expensive, non-invasive test that can be performed at home can potentially be used in place of an EGD with fluid collection and culture, particularly to monitor response to treatment.
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The Microenvironment in Barrett's Esophagus
Austin, MN; Rochester, MN
This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA ...
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Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
Rochester, MN
The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.
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Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Rochester, MN
Does the small bowel microbiota in healthy individuals change after consumption of a Western diet?
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A Study to Evaluate Bile Acid Reflux in Patients with Recurrent Barrett’s Esophagus
Rochester, MN
The purpose of this study is to establish the mean concentration of duodenogastric refluxed bile acid in patients with recurrent Barrett’s esophagus (BE) -related intestinal metaplasia, dysplasia, or EAC versus patients who achieved complete remission for at least > 1 year following initial endoscopic intervention, and to establish the composition of duodenogastric refluxed bile acid in patients with BE-related recurrent intestinal metaplasia, dysplasia, or EAC versus patients who achieved complete remission for at least > 1 year following initial endoscopic intervention.
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Nitrates and IL-8 in Barrett's Esophagus
Rochester, MN
The purpose of this study is to determine serum, saliva, and tissue levels of nitrates in patients with normal squamous epithelium, erosive esophagitis, non-dysplastic BE (NDBE), and BE with high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC); to compare serum and tissue levels of IL-8 with varying levels of BE dysplasia and EAC; and to determine whether there is an association between nitrate levels and IL-8.
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Exploring Duodenal Biopsies as a Biomarker of Pancreatic Cancer
Rochester, MN
To determine whether the microbiome, metagenome and metabolome of the tissue of the second portion of duodenum of patients with pancreatic cancer are different from that of patients with benign conditions not affecting the pancreas.
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A Study to Evaluate Volumetric Laser Endomicroscopy with Intelligent Real-time Image Segmentation (IRIS)
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to examine how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric Laser Endomicroscopy).
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Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Jacksonville, FL; Rochester, MN
The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.
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A Study to Evaluate the Use of Confocal Laser Endomicroscopy as an IMaging Biomarker (CLIMB Study) for the Diagnosis of Pancreatic Cystic Lesions
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate EUS-nCLE as an imaging biomarker and PCL fluid DNA analysis as a molecular biomarker for the management of pancreatic cystic lesions (PCLs).
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A Study to Establish a Registry for Treatment of Post-hemorrhagic Hydrocephalus in Neonates
Rochester, MN
The purpose of this study is to establish a prospective, standardized data collection for the patients who undergo surgical treatment of progressive post-hemorrhagic hydrocephalus in neonates with the focus on comparing neuroendoscopic lavage (NEL) with other standard treatment options such as external ventricular drainage (EVD), ventricular access device (VAD) and ventricular subgaleal shunt (VSGS).
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Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease
Rochester, MN
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ...
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AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
Rochester, MN
To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.
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A Study to Evaluate Endoscopic Full Thickness Resection Outcomes
Jacksonville, FL
The purpose of this study is to review the clinical outcomes associated with use of a novel endoscopic full-thickness resection device that recently became available in the United States.
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A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System (MICAS) for Chronic Subdural Evacuation
Rochester, MN
The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.
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A Study of the Safety and Effectiveness of Metal Stents for the Management of Gastrointestinal Strictures
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of coxial lumen apposing metal stents in patients with strictures (narrowing) within the gastrointestinal tract.
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Endoscopic Necrosectomy vs. Step-up Endoscopic Interventions Pragmatic Trial
Jacksonville, FL
The aim of this pragmatic, randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature ...
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Suturing Pattern for Endolumenal Stenting Procedures
Rochester, MN
The purpose of this study is to track endoscopically-placed stents and demonstrate that either suturing pattern is equivalent.
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Quality of Life After Endoscopic Skull Base Surgery
Rochester, MN
The goal of this study is to determine the olfactory outcomes and quality of life outcomes associated with cautery upper limb vs cold knife upper limb nasal septal incision.
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A Study to Evaluate the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps Compared to Colonoscopy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).
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A Study to Compare the Effectveness of Colon Capsule Endoscopy versus Computed Tomographic Colonography in Screening to Identify Colon Polyps
Rochester, MN
The purpose of this study is to compare the effectiveness of Colon Capsule Endoscopy versus Computed Tomographic Colonography for the screening of colon polyps in the usual screening population.
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A Study Establishing a Registry for Endoscopic Suturing (ES)
Jacksonville, FL
The purpose of this study is to determine patient outcomes (survival, additional endoscopic or surgical procedures) with an endoscopic suturing technique at predetermined intervals compared to historical controls when applicable. To evaluate the effectiveness, safety, and durability of trans-orifice endoscopic suturing therapy for revision of bariatric procedures as well as study the safety, efficacy, and durability of preventative fixation of GI endoprosthetics.
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Rochester, MN
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
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A Study to Evaluate the Otonexus Ultrasound Otoscope
Rochester, MN
The purpose of this study is to evaluate usability of the OtoNexus device when used in pediatric and adult patients in a clinical setting to detect middle ear effusion, and to determine if it is viral, bacterial, or mucoid.
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Role of Wearable Smart Devices During Endoscopic Procedures
Rochester, MN
The purpose of this study is to assess the accuracy and safety of smart watches in the endoscopy suite for patients undergoing gastrointestinal endoscopic procedures with sedation.
The term wearable technology encompasses a wide spectrum of devices worn on or near a person. Market research suggests that one in five Americans are users of wearable technology with the market currently valued at over 30 billion dollars annually. These devices have the ability to record physical information, ranging from heart rate to pulse oximetry, as well as audio and video. These devices are often marketed to improve health and well-being, ...
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Dietary Sugar Absorptive Phenotype for Prediction of Weight Loss Outcome
Jacksonville, FL
Using stem cell derived intestinal epithelial cultures (enteroids) derived from obese (BMI> 30) patients and non-obese and metabolically normal patients (either post-bariatric surgery (BS) or BS-naïve with BMI < 25), dietary glucose absorption was measured. We identified that enteroids from obese patients were characterized by glucose hyper-absorption (~ 5 fold) compared to non-obese patients. Significant upregulation of major intestinal sugar transporters, including SGLT1, GLU2 and GLUT5 was responsible for hyper-absorptive phenotype and their pharmacologic inhibition significantly decreased glucose absorption. Importantly, we observed that enteroids from post-BS non-obese patients exhibited low dietary glucose absorption, indicating that altered glucose absorption ...
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Human Factors Validation of OtuVU
Rochester, MN
The purpose of this study is to assess whether the OtoVU endoscopy system is safe, effective, and works as intended for.
The purpose of the human factors validation study is to evaluate the usability of the OtoVU system.
The purpose of the design validation study is to establish that the OtoVU system meets the intended use and to establish that the OtoVU system meets the user needs.
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Endoscopic Resection of Large Colorectal Polyps
Jacksonville, FL
The purpose of this study is to understand how to improve polyp resection of large polyps, and how to make it as effective and as safe as possible.
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A Study to Evaluate the Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Jacksonville, FL
The goal of this research is to determine the natural history of Barrett's esophagus (BE) using tethered capsule endomicroscopy (TCE) in patients undergoing surveillance endoscopy.
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Clinical Study Comparing PillCam ® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease
Scottsdale/Phoenix, AZ
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ...
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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
Rochester, MN
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
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Quality Assessment of Colon Capsule Endoscopy
Rochester, MN
The primary aims of the study include determining the patient’s experience with colon capsule endoscopy (CCE) and the associated bowel preparation. In addition, the nursing staff experience with administration of the colon capsule will also be noted. Finally, the physician’s experience with interpretation of the colon capsule images. The secondary aim of this study is preliminary evaluation of the diagnostic yield of CCE compared to CT colonography (CTC).
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A Study to Assess Clonal Diversity of Freshly Taken ESD Specimens
Rochester, MN
Inclusion Criteria:
- Patients with Barrett’s Esophagus (BE) or Esophageal Adenocarcinoma (EAC) that are planned for Endoscopic Submucosal Dissection (ESD) treatment.
Exclusion Criteria:
- Patients without BE or EAC or that are not planned for ESD treatment.
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Study to Create a Registry to Collect the Findings and Outcomes of Patients Undergoing Contrast-Enhanced Harmonic Endoscopic Ultrasound (CE-EUS)
Jacksonville, FL
The purpose of this study is to describe the findings and outcomes of patient undergoing contrast-enhanced harmonic endoscopic ultrasound (CE-EUS) imaging. A registry will be created to monitor for possible procedure adverse events and to perform descriptive statistics for the patients who undergo this procedure.
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Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Rochester, MN
The purpose of this study is to identify a predictive model for worsening of preexisting gastroesophageal reflux disease (GERD) or development of de novo GERD after laparoscopic sleeve gastrectomy (LSG) by using EndoFLIP, upper endoscopy and esophageal manometry to assess patients preoperatively in a discovery cohort. This prospective predictive model will then identify sensitivity, specificity, positive and negative predictive values for prediction of worsening or de novo GERD.
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Dielectric Tissue Characterization
Rochester, MN
In this prospective feasibility study we will measure the dielectric properties of various gastrointestinal tissue types using freshly excised resection specimens. Patients undergoing gastrointestinal endoscopy and clinically indicated endoscopic resection will be approached for study participation. Immediately following resection, the specimen will be imaged using volumetric laser endomicroscopy for tissue characterization and precise localization of complex permittivity measurements. The resection specimen will then be submitted for routine histopathological assessment. Our group has previously used a similar framework for the study of various image enhancement technologies without impacting the care of our patients. In order to adequately measure the dielectric properties ...
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Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)
Scottsdale/Phoenix, AZ
The purpose of this study is to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).
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Complications Associated with Primary Placement of Radiologically-Inserted Gastrostomy versus Percutaneous Endoscopic Gastrostomy for Feeding
Rochester, MN
The use of long-term enteral tube feeding has increased dramatically in the United States and worldwide. Radiologically-inserted gastrostomy (RIG) or percutaneous endoscopic gastrostomy (PEG) are the most common techniques used for long term enteral feeding. Gastrostomy-related complications are classified as major (peritonitis, abscess, bleeding requiring intervention/transfusion, bowel perforation, death) or minor (superficial infection, skin erosion, bleeding not requiring intervention, exit site leakage or tube complication [occluded, malpositioned/dislodged, damaged]). Not many studies have compared the outcomes and major and minor complications associated with RIG versus PEG. The primary objectives of this study are to assess pain as well as major and minor complications with gastrostomy-tube ...
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A Study of Disease Risk Caused by Tumor Particles Getting into the Blood from Endoscopic Ultrasound Guided Fine Needle Aspiration
No Locations
The purpose of this study is to assess the risk for cancer spread caused by the leaking of tumor particles into the blood from the biopsy procedure endoscopic ultrasound guided fine needle aspiration.
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Eosinophils in Human Adipose Tissue
Scottsdale/Phoenix, AZ
This study aims to assess adipose tissue-eosinophil content and adiopose tissue metabolism 3 months after endoscopic gastroplasty weight loss procedure.
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A Study to Evaluate the Effectiveness of a Healthy Living Weight Loss Program in Obese Patients Undergoing Bariatric Endoscopy on Weight Loss Outcomes
Rochester, MN
The purpose of this study is to compare weight loss, improvement of comorbidities, improvement of lipid profile, blood sugar in patients undergoing endoscopic sleeve gastroplasty or intragastric balloon between patients who are in a weight loss program and those who are not.
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A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
Rochester, MN; Scottsdale/Phoenix, AZ
The primary aim of this pilot and feasibility, hypothesis-generating study therefore is to evaluate the effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham endoscopic surgery on symptoms in patients with diabetic or idiopathic gastroparesis.
Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. There are few effective treatments available; more recently, a procedure called G-POEM (gastric peroral endoscopic myotomy) has been advocated to relieve symptoms by improving gastric emptying; however, it is not ...
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Study to Evaluate Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to investigate if Hybrid Argon Plasma Coagulation (HAPC) is non-inferior to Radiofrequency Ablation (RFA) in the stricture-free eradication of the dysplastic Barrett's Esophagus (BE) epithelium.
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A Study to Compare COVID-19 Nasal Testing to Gastric, Bile, or Intestinal Testing
Rochester, MN
The primary aim of this study is to determine if there is any evidence of viral shedding within the gastrointestinal or pulmonary system in patients with a prior recent negative nasopharyngeal PCR test. This will be of critical importance to the practice of endoscopy during this pandemic as it will help: 1) determine if a pre-endoscopy testing strategy is adequate to ramp-up access to semi-urgent and eventually elective procedures, while allowing the decreased utilization of limited or costly personal protective equipment (e.g., N95 respirators) while still keeping the GI endoscopy staff safe; and 2) realize the false negative rate of pre-procedural testing, which is vital to inform procedural practice policy and operations.
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Endoscopic Gastric Reduction for Weight Management
Rochester, MN
The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves ...
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Revision of RYGB For The Treatment Of Weight Regain Using the OverStitch Device
Rochester, MN
This study will review and analyze the literature regarding endoscopic revision of Roux-en-Y gastric bypass surgery for the treatment of weight regain using the OverStitch, a minimally invasive endoscopic device. This study will also include information about patients who underwent TORe as part of their clinical evaluation and treatment for weight regain by chart review.
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Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
Rochester, MN
Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We are completing ...
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Image Guidance Navigation Provides Objective Feedback That Can Be Used to Evaluate Surgical Trainees and Consultants
Rochester, MN
Trudi will give us the data points to address residents and consultants skill level and areas of weakness during endoscopic sinus surgeries. (ESS)
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A Study to Evaluate Endoscopic Endonasal Skull Base Surgery and Pituitary Surgery Quality of Life
Rochester, MN
The objectives of this study are to:
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- Measure the short and long-term overall and nasal-specific quality of life (QOL) impact of patients undergoing Endoscopic Endonasal Skull Base Surgery (EESBS) for pituitary and sellar lesions.
- Determine the relative difference in QOL impact of EESBS for patients undergoing surgery for functional and nonfunctional pituitary adenomas.
- Generate baseline data to development and validate a site-specific endoscopic-specific comprehensive QOL for EESBS.
- Particular tumors of interest include pituitary tumors, Rathke’s cleft cysts, craniopharyngiomas, clival chordomas and chondrosarcomas.
- Specific QOL aims focus on olfaction (sense of smell), gustation (sense of taste) and nasal function.