The Captivator EMR Registry

Completed

Conditions studied: Barrett's Esophagus

In brief

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

Key facts

Study ID

NCT02482701

Run by

Boston Scientific Corporation

People needed

291

Starts

2015-08-01

Expected to finish

2017-06-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years.
• 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.
• Subject is scheduled for endoscopic resection of present neoplasia
• Subject is amenable to EMR with no suspicion of submucosal invasion, based on the macroscopic appearance and/or endosonography upon earlier endoscopy.
• Subject is taking PPI (Proton Pump Inhibitor) BID (Twice Daily) 40 mg (or equivalent dosage).
• Subject is willing to participate, fully understands the content of the informed consent form, and signs the informed consent form.

You may not qualify if…

• 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.
• Presence of esophageal stenosis preventing passage of a therapeutic gastroscope.
• Endoscopically visible scarring by any cause of the intended treatment zone.
• Esophageal varices.
• Subject has known or suspected esophageal perforation.
• Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).

Where it is running

• 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
• Addenbrookes Hospital — Cambridge, Cambridgeshire, United Kingdom
• University College Hospital — London, United Kingdom
• Nottingham Digestive Disease Centre, NIHR — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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