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A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
Rochester, Minn.
This study is being done to assess the use of scaffold products in promoting constructive healing as determined by the ability of the resection site to lift during follow-up.
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Clonal Diversity of Freshly Taken ESD Specimens
Rochester, Minn.
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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Endoscopic Image and Pathology Correlation for Duodenal Biopsy Findings Using Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology
Rochester, Minn.
The purpose of this study is to match endoscopic images with standard of care endoscopic biopsies to determine if the images can diagnose as effective as biopsies for duodenal/small bowel biopsies.
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Eradicating Barrett's Esophagus Using Radiofrequency Ablation or a Novel Hybrid Argon Plasma Coagulation Technique (BURN) (BURN)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
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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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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Minimal Risk Registry of Endoscopic Image and Pathology Correlation Using Fujifilm 7000 Blue Light Imaging System With 4 Light-emitting Diode (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.,
Rochester, Minn.
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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Phase II Study of EUS-guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02) (VERTPAC-02)
Rochester, Minn.
The goal of project is to target of locally advanced pancreatic cancer (LAPC) with a photodynamic therapy (PDT) to evaluate response of tumor.
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Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of the Interscope Endorotor® Mucosal Resection System With Continued Ablative Therapy In Subjects With Refractory Dysplastic Barrett's Esophagus
Rochester, Minn.
The aim of the clinical trial is evaluate the EndoRotor®’s ability to completely remove areas of Barrett’s metaplasia considered refractory after failed ablative therapy.
Contact Us for the Latest Status
Closed for Enrollment
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Application of the Microbiome and Microenvironment to Novel Non-Endoscopic Screening and Surveillance in Barrett's Esophagus (BETRNet2)
Austin, Minn.,
Rochester, 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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Clinical Trial to Evaluate Safety and Dose Response Using the C2 Cryoballoon™ Full Ablation System for the Treatment of Non-Dysplastic, Low Grade Dysplastic or Indefinite for Dysplasia Barrett’s Esophagus
Rochester, Minn.
The primary objective is to determine the safety of the C2 CryoBalloon Full Ablation System (“CryoBalloon Full”) used at increasing doses in subjects with non-dysplastic, Low-Grade Dysplastic (LGD) or indefinite for dysplasia Barrett’s Epithelium (BE).
A secondary objective is to evaluate CryoBalloon Full efficacy, evaluated by the percentage of regression of BE after ablation at a particular dose with the Full Ablation System.
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CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
Rochester, Minn.
To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro ablation .
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CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation (BEATS-RF)
Rochester, Minn.
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
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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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Enhanced Detection of Dysplasia by Confocal Fluorescent Microscopy in Ex-Vivo Barrett’s Esophagus Tissue from Clinically-Indicated Endoscopic Mucosal Resection
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the performance characteristics of Optiscan, a handheld confocal fluorescent microscopy system, along with Ninepoint and Cellvizeo a probe based confocal microscopy system in ex-vivo Barrett’s esophagus tissue obtained from clinically-indicated, endoscopic mucosal resection (EMR) in patients scheduled for clinically indicated surveillance of Barrett's Esophagus.
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Identification of C. difficile Infected Stool by Electronic Nose
Rochester, Minn.
The purpose of this study is to see how effective a new technology called the electronic nose is in identifying specific infection (C. difficile) from stool samples, by analyzing the gasses the stool gives off.
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Identification of Features Associated with Dysplasia Using the NvisionVLE® Imaging System Pilot Trial (DDP)
Rochester, Minn.
The purpose of this study is to evaluate the performance of the NvisionVLE® Imaging System for determining features of dysplastic Barrett's Esophagus by collection and analysis of medical record information, imaging data, and pathology results. The study is for patients who have a prior biopsy-confirmed diagnosis of Barrett's esophagus with dysplasia and are scheduled to have an endoscopic evaluation.
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Notch Signaling and Novel Biomarkers for Barrett’s Esophagus (BETRNet)
Jacksonville, Fla.,
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
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Performance of Clutch Cutter vs. Conventional Endoscopic Submucosal Dissection Methods among Gastroenterology Trainees in an Ex Vivo Model
Rochester, Minn.
The purpose of this study is to assess for differences between Clutch Cutter vs. conventional endoscopic submucosal dissection techniques with regards to; Time to incision; Time to dissection; Total procedure time; Number of perforations; and Ease of use as determined by participant questionnaire.
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Pilot Study of Upper Midwest Native Americans and Medical Providers Perceptions of Colon Cancer
Rochester, Minn.
The purpose of this study is to survey the Native Americans and their medical providers from two upper midwest communities for their perceptions about colon cancer, and the benefits or barriers for screening.
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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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Wide Area Transepithelial Sample Esophageal Biopsy Combined with Computer Assisted 3-dimensional Analysis (WATS) for the Detection of Esophageal Dysplasia: A Prospective, Randomized, Tandem Study (WATS)
Rochester, Minn.
The purpose of this study is to see if collecting cells from the lining of the esophagus with a brush in addition to the biopsies taken for standard medical care will have a better rate of finding cancer cells related to having Barrett's esophagus.
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