Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.

Captivator™ EMR

Jacques Bergman, MD

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

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

Successful resection is assessed during the EMR procedure

The number of resection per procedure is assessed during the EMR Procedure

Total procedure time is assessed during the EMR procedure

Study subjects will have follow-up visits after the EMR procedure during which the occurrence of adverse events related to the Captivator EMR procedure or device will be assessed. These visits will occur at the following time points:

* Immediately following the EMR procedure (Post procedure evaluation)
* 48 hour telephone call
* 30 day telephone call
* Unscheduled clinic visits will be performed in-between protocol required follow-up, as necessary.

Once the 30 day phone call is complete, the subject will have completed the study.

Accessory device use is assessed during the EMR procedure

Endoscopic management of complications is assessed during the EMR procedure

Accessory devices used to complete resection is assessed during the EMR procedure

Histopathology of resection specimens is performed per standard of practice at each participating study center. Results are expected within approximately 7 days of the EMR procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Captivator EMR Registry	NCT02482701	Barrett's Esoph...	Captivator™ EMR	18 Years - 80 Years	Boston Scientific Corporation
The Captivator EMR Registry	NCT02482701	Barrett's Esoph...	Captivator™ EMR	18 Years - 80 Years	Boston Scientific Corporation

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