Recruiting

OFDI Imaging System

Sponsor:

Massachusetts General Hospital

Code:

NCT02947971

Conditions

Barrett's Esophagus

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

Interventions

Experimental OFDI Imaging

Study Details

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 participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.

Conditions

Barrett's Esophagus

Study ID

NCT02947971

Start date

Apr 15, 2016

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • A previous diagnosis of BE (not an inclusion criteria for healthy volunteers)
  • Participants 18 years and older with a previous diagnosis of GERD
  • Participants 14 years and older with a previous diagnosis of EoE (not an inclusion criteria for healthy volunteers)
  • Health participants over the age of 18 but less than 85 years of age
  • Participants must be able to give informed consent
  • Participants must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

  • Participants over 85 years of age
  • Participants with the inability to swallow pills and capsules.
  • Participants with a strong gag reflex
  • Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
  • Participants who are pregnant. In case of women of child bearing age, we will ask them if they are pregnant and if unsure; ask them to take a pregnancy test.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: OFDI Imaging

Experimental OFDI Imaging

Interventions

Experimental OFDI Imaging

Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Juleen Guoy, RN

617-726-5317Tearneylabtrials@partners.org

Anita Chung, RN

617-724-4515Tearneylabtrials@partners.org

Locations

Massachusetts General hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Anita Chung, RN

617-643-6092Tearneylabtrials@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Keywords

  • Device
  • OFDI
  • Tethered Capsule Endomicroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-22.