Clinical Trial: Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

Brief Summary: The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Detailed Summary:

Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.


Sponsor: Massachusetts General Hospital

Current Primary Outcome: Assessment of quality and performance of Compact Imaging System (CIS) [ Time Frame: 5-7 Minutes of imaging ]

Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: April 14, 2016
Date Started: September 2015
Date Completion: February 2018
Last Updated: October 26, 2016
Last Verified: October 2016