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COMPLETED

The Captivator EMR Registry

An International, Multicenter, Prospective, Post Market Registry Using a New Device for Endoscopic Resection of Early Neoplasia in Barrett's Esophagus

NCT02482701•Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

To confirm performance of the Captivator™ EMR device for resection of early neoplasia in Barrett's Esophagus.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-80 years.
•2. Barrett's esophagus with a visible abnormality confirmed upon prior endoscopy. A visible abnormality is described as meeting one or more of the following definitions:
•* Lesion is detected as visible based on white light imaging with any macroscopic appearance according to the Paris Classification and is also endoscopically resectable.
•* Lesion is detected by narrow band imaging (NBI), but without any other specific characteristics for a visible lesion.
•* Lesion is confirmed to contain high grade dysplasia and/or carcinoma upon prior biopsy.
•3. Subject is scheduled for endoscopic resection of present neoplasia
•4. Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
•5. Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
•6. Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

Exclusion Criteria

•1. Subject has previously undergone endoscopic therapy for esophageal neoplasia, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation, argon plasma coagulation or radiotherapy.
•2. Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
•3. Endoscopically visible scarring by any cause of the intended treatment zone.
•4. Esophageal varices.
•5. Subject has known or suspected esophageal perforation.
•6. Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).

Locations (13)

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

University Hospital Leuven

Leuven, Belgium

St. Michael's Hospital

Toronto, Ontario, Canada

Krankenhaus Barmherzige Bruder

Regensburg, Bavaria, Germany

EVK Krankenhaus

Düsseldorf, Germany

Academic Medical Center

Amsterdam, AZ, Netherlands

Catharina Hospital

Eindhoven, EJ, Netherlands

St. Antonius Hospital

Nieuwgein, NL, Netherlands

Erasmus MC - University Medical Center

Rotterdam, Netherlands

Key Dates

Start Date

August 1, 2015

Primary Completion Date

May 1, 2017

Completion Date

June 1, 2017

Last Updated

March 7, 2018

Enrollment

291

ACTUAL participants

Conditions

Barrett's Esophagus

Interventions

Captivator™ EMR

DEVICE

A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer

NCT06523374

Barrett's EsophagusEsophageal Adenocarcinoma

View study

RECRUITING

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

NCT02198976

Barrett's Esophagus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Captivator EMR Registry

Inclusion Criteria

Exclusion Criteria

A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer

Australian Barrett's Cohort With Dysplasia and Early Cancer Study

Barrett's Esophagus Related Neoplasia (BERN) Project

CBAS180 De-escalation Study

Progression of Gastroesophageal Reflux Disease and Barrett's Esophagus and the Creation of a Barrett's Registry

Cell Marker Predictors in Barrett's Esophagus