The Captivator EMR Registry



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/17/2018
Start Date:August 2015
End Date:June 2017

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

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


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).
We found this trial at
3
sites
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Michael B. Wallace, MD
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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Leuven,
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Rochester, Minnesota 55905
Principal Investigator: Kenneth K. Wang, MD
Phone: 507-255-7495
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Rochester, MN
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