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COMPLETEDNCT02482701

The Captivator EMR Registry

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

Lead sponsor: Boston Scientific Corporation•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boston Scientific Corporation

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 7, 2018Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment291

Start dateAug 2015

Last updatedMar 7, 2018

Condition

Barrett's Esophagus

Locations shown

Mayo Clinic

Jacksonville, Florida

Mayo Clinic

Rochester, Minnesota

University Hospital Leuven

Leuven

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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: May 10, 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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