NCT02947971Recruiting
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Source: ClinicalTrials.gov · Last updated 22 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 14 Apr 2016
- Start date
- 15 Apr 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- Massachusetts General Hospital
- NCT number
- NCT02947971
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Apr 2016 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
Age
- Participants over 85 years of age
- 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.
Other
- Participants with the inability to swallow pills and capsules.
- Participants with a strong gag reflex
Who the study is looking for
- 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.
Age in the registry: 14 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.