Clinical Trials

To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

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.

This study is designed to evaluate the effect of dexlansoprazole QD and BID dosing on the recurrence of intestinal metaplasia (IM) in subjects who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

This study is to identify potential markers from esophageal biopsies and brush cytology for feasibility of use in stool specimens for detection of Barretts Esophagus.

The purpose of this study is to examine how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric Laser Endomicroscopy).

To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic therapy for Barrett's Esophagus related metaplasia.

The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

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.

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.

The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using truFreeze spray cryotherapy within the currently recommended therapeutic range. Secondary objectives are the determination of safety related outcomes such as esophageal stricture.

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.

To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community.

To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient.

Will oral supplementation with Omega 3 free fatty acids in obese Barrett's esophagus subjects downregulate pro-neoplastic and pro-inflammatory pathways in the esophagus to anti-inflammatory pathway?

The purpose of this study is to determine the feasibility and tolerability of obtaining esophageal VLE images using the NvisionVLE® Imaging System Capsule Probe.

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.

The purpose of this multicenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication="" of="" barrett's="" esophagus="" (be)="" after="" 2="" rfa="">

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (dexlansoprazole) will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

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.

The purpose of this study is to develop an evidence-based management decision aid for patients who have Barrett's Esophagus with low grade dysplasia, called BE Choice. To evaluate the impact of the developed decision aid (BE Choice) on patient-centered outcomes, assessments will be made of patient knowledge, decision conflict, patient involvement in decision-making, treatment choice, and outcomes when compared to ‘usual specialist care’.

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.

This randomized phase II trial studies the safety of and how well acetylsalicylic acid (Aspirin) works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether acetylsalicylic acid can prevent it from returning after it has been successfully treated.

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.

To assess the response of persistent Barrett's Esophagus and/or dysplasia to focal cyro ablation .

Will EG Scan (transnasal endoscopy) determine presence of Barrett's Esophagus, esophagitis and hiatal hernia as well as standard sedated endoscopy.

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 ...

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.

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.

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).

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.

The purpose of this study is to evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus.

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.

This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

The purpose of this study is to learn more about the prevalence of gastroesophageal reflux among patients with esophagitis using long term proton-pump-inhibitor use.

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.

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.

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.