The Captivator EMR Registry

Boston Scientific

Status: Completed

Conditions: Barrett's Esophagus

Treatments: Device: Captivator™ EMR

Study type: Observational

Funder types: Industry

Identifiers

NCT02482701

91038126

Details and patient eligibility

About

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

Enrollment: 291 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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).