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A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
To document impact of EUS-FNA needle size and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
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A Randomized, Double-Blind, Comparative, Effectiveness and Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger than 2 cm
Jacksonville, Fla.
The purpose of this study is to assess the effectiveness of SIC 8000 injected into the submucosa under polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions to provide a lift to them prior to grasping and cutting with a snare during endoscopic removal procedures.
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Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging – A Patient Registry
Jacksonville, Fla.
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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Endoscopic Full Thickness Resection Outcomes
Jacksonville, Fla.
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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Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study (Large Polyp Study Group, Study III)
Jacksonville, Fla.
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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High Resolution Optical Imaging of Esophageal Tissue Using the NvisionVLE™ Imaging System Registry
Jacksonville, Fla.
The purpose of this registry of patients undergoing EGD or endoscopy is to provide a collection of patient NvisionVLE™ (volumetric laser endomicroscopy) procedural data for participating physicians, including, but not limited to, imaging data, clinical utility data, demographics, pathology, treatment, and long term follow up.
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International Multicenter Registry of Cancer of the Pancreas Screening (CAPS) (CAPS)
Jacksonville, Fla.
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To determine whether a surveillance program consisting of in a cohort of high-risk individuals results in an excess number of detected and surgically resected high-grade premalignant lesions and early stage pancreatic cancers compared to the natural disease development and manifestation.
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To determine whether above mentioned strategy results in an improved survival
compared to high-risk individuals not under surveillance and compared to the survival
statistics of sporadic pancreatic cancer.
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To determine patient and lesion characteristics by which precursor lesions can be stratified according their risk of malignant transformation.
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Large Polyp Study (LPS) II: Cold endoscopic resection of large colorectal polyps: A randomized trial (Cold snare EMR trial) (Cold snare)
Jacksonville, Fla.
The primary aim of the study is to compare safety and effectiveness of two methods of endoscopic resection of large colorectal polyps: cold snare EMR (without electrocautery) vs. hot snare EMR (with electrocautery).
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Minimal Risk Registry of Endoscopic Image and Pathology Correlation Using Fujifilm 7000 Imaging System with 4-LED Multi Light Technology
Jacksonville, Fla.,
Rochester, Minn.
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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Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Jacksonville, Fla.
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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Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study
Jacksonville, Fla.
The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.
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PancreaSeq® for Risk of Malignancy Assessment in Pancreatic Cystic Lesions
Jacksonville, Fla.
The purpose of this study is to evaluate the validity and accuracy of the PancreaSeq assay on long-term outcomes of pancreatic cystic lesions (PCL).
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Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
Jacksonville, Fla.
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
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Prospective Evaluation of the Clinical Utility of Budesonide for the Prevention of Esophageal Strictures after Endotherapy
Jacksonville, Fla.
Surgery has been historically the mainstay treatment for advanced pre-malignant lesions and early esophageal cancers. However, esophagectomy is associated with significant morbidity and mortality. With the advance of therapeutic endoscopy, there has been a growing interest and application of endoscopic resection and mucosal ablative techniques for the treatment of these diseases. Esophageal stricture(ES) formation has become an increasingly recognized complication of extensive endoscopic mucosal ablation and/or resection. The resultant symptomatic stricture development can significantly impair a patient's quality of life. Endoscopic therapy of esophageal strictures with balloon dilation and/or local steroid injection is invasive, costly, and associated with the potential risk of perforation. Recently, oral corticosteroids have been introduced for the prevention of esophageal stricture after endoscopic submucosal dissection.
Budesonide is a synthetic steroid with topical anti-inflammatory properties and high first-pass metabolism; thus, potentially less systemic absorption and side effects.
Hypothesis: Oral budesonide prevents esophageal stricture formation in patients who underwent radical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for advanced premalignant esophageal lesions or superficial esophageal cancers.
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Prospective, Randomized, Multicenter, Tandem Study Evaluating the Safety and Effectiveness of the CB-17-08 Augmented Endoscopy System for the Detection of Mucosal Colorectal Polyps in Adult Patients Undergoing Screening or Surveillance Colonoscopy for CRC
Jacksonville, Fla.,
Eau Claire, Wis.,
Scottsdale/Phoenix, Ariz.,
La Crosse, Wis.
The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).
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Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial. (SCAR)
Jacksonville, Fla.
The purpose is to investigate whether a simple additional treatment applied during colonoscopy (called 'soft' coagulation) can reduce the risk of recurrence of polyp at the area where the polyp was removed. After a large polyp is removed it is known that there is a 20% chance that a small recurrence of polyp occurs at the site of removal can occur within 5 months of the polyp being removed. This in theory will burn off tiny polyp tissue, which is usually not visible to the naked eye. This additional treatment may possibly reduce the risk of polyp recurrence.
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