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An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to confirm the performance of the Captivator™ endoscopic mucosal resection device for resection of early tumor growth in Barrett's Esophagus.
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Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus (BETRNet2)
Rochester, Minn.,
Austin, Minn.
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 markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.
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DIELECTRIC CHARACTERIZATION OF LUMINAL GASTROINTESTINAL TISSUE: A FEASIBILITY STUDY
Rochester, Minn.
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 of healthy tissue, we also propose performing measurements in freshly resected gastrointestinal surgical specimens.
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Electronic Nose Identification of Fasting and Non-fasting Breath Profiles (Fast Breath)
Rochester, Minn.
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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Evaluation of Bile Acid Reflux in Patients with Recurrent Barrett’s Esophagus
Rochester, Minn.
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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Evaluation of Bowel Preparation Adequacy by FAIMS Analysis of Fecal Headspace Volatile Organic Compounds in Patients Undergoing Colonoscopy
Rochester, Minn.
The purpose of the study is to determine the efficacy of the Lonestar FAIMS platform in distinguishing adequately versus inadequately prepped patients by fecal headspace analysis of volatile organic compounds.
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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)
Rochester, Minn.
The purpose of this research is to evaluate the accuracy of a medical device that has been developed to automatically find polyps (small growths) during colonoscopies. The device uses a computer to detect and highlight potential polyps from the usual video images made during a colonoscopy, and such detections will be visible to the doctor during the regular colonoscopy procedure. This medical device is called Endoscopy Video Assistance for Colonoscopy (EVA-C). EVA-C, an investigational device, has been developed to assist the doctor in identifying possible polyps, but is not meant to replace their decision making.
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Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia (VLE EMR)
Rochester, Minn.
This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology
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Significance of Glandular Atypia in Barrett’s Esophagus Determined by Volumetric Laser Endomicroscopy
Rochester, Minn.
The primary purpose of this study is to systematically measure the severity and extend of glandular atypia in patients with Barrett’s esophagus using volumetric laser endomicroscopy.
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Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
Rochester, Minn.
This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.
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The Association Between Nitrates, Nitrosylated Proteins, and Interleukin-8 in Barrett’s Esophagus and Esophageal Adenocarcinoma (BENIL-8)
Rochester, Minn.
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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The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett’s Esophagus after Complete Eradication of Intestinal Metaplasia
Rochester, Minn.
The purpose of this study is to determine whether the use of a volumetric laser endomicroscopy (VLE) scan of a patient with Barrett's Esophagus who has been treated with endoscopic therapy and achieved CRIM can predict disease recurrence. This approach could help identify individuals at low risk of recurrence who may benefit from decreased frequency of surveillance endoscopy. By the same token, a VLE scan could also help identify individuals at high risk of recurrence who may benefit from earlier therapeutic intervention.
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Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study (IRIS)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
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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