Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy

Description

The goal of this research is to follow Barrett's Esophagus patients for 3 years using the tethered capsule endomicroscopy device with distal scanning and a compact imaging system in a multi-site clinical study.

Study Start Date

April, 04 2017

Estimated Completion Date

December 2020

Interventions

  • Device: Tethered Capsule Endomicroscopy (TCE)

Study ID

Massachusetts General Hospital -- 2017P000604

Status

Recruiting

Trial ID

NCT03459339

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

500

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Subjects over the age of 18
  • Subjects who are capable of giving informed consent
  • Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy,
  • Subjects who had or will have a standard of care EGD within 15 months
  • Subjects must have no solid food for at least 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure

Exclusion Criteria

  • Subjects with prior endoscopic ablation or resection treatment of BE at enrollment visit
  • Subjects with esophageal fistula and/or esophageal strictures
  • Subjects with the inability to swallow capsules
  • Self reported pregnancy

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Guillermo Tearney MD 617-724-2979 gtearney@partners.org
Columbia University Medical Center - New York, New York 181.2 miles John Poneros MD 212-305-1909 Jmp14@columbia.edu
Mayo Clinic Jacksonville - Jacksonville, Florida 1,015.8 miles Michael Wallace MD 904-953-7190 wallace.michael@mayo.edu
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles Kenneth Wang MD None wang.kenneth@mayo.edu
VA Clinic - Kansas City, Missouri 1,247.2 miles Prateek Sharma MD 816-921-9311 psharma@kumc.edu

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