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A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule

This study is testing a new, inexpensive device called the Retro-TCE (Retrograde Tethered Capsule Endomicroscope) capsule to take pictures of your lower gastrointestinal (GI) tract without needing sedation. The capsule is about the size of a fish oil supplement and is attached to a string. It will be gently inserted and moved upwards in your lower GI tract to capture images in real-time. Researchers want to see if this capsule can take clear, high-quality images. You might be able to join if you are between 18 and 75 years old, are generally healthy, or have Lynch Syndrome. The study plans to enroll 30 participants, and the current recruitment status is unclear.

Study design
This is an interventional study where all 30 participants will receive the same intervention: imaging with the Retro-TCE capsule.
What's involved
You will receive the Retro-TCE capsule intervention. Imaging data is collected during this procedure.
Compensation
Not stated in the trial record.
Follow-up
Imaging data will be analyzed within one year of collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219537

A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule

Recruiting
NAAges 18–75InterventionalDevice feasibility
Massachusetts General Hospital
~30 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability of the R-TCE capsule to acquire quality images of the lower GI tract
Measured over Imaging data is collected during the study procedure and analyzed within one year of collection.

Conditions

Lynch Syndrome
Crohn Disease
Inflammatory Bowel Diseases
Healthy

Explore related trials

Crohn DiseaseHealthyInflammatory Bowel DiseaseLynch Syndrome

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Guillermo Tearney, M.D., PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Nitasha Bhat, M.D.
[email protected]
617-643-6092
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Are 18 years of age or older.
Are healthy or with a confirmed diagnosis of Lynch Syndrome
Are capable of giving informed consent.
Are able to follow bowel prep instructions
Had a colonoscopy 0-24 months prior that did not show any abnormalities or individuals who report no gastrointestinal symptoms and no knowledge of any lower GI tract disease or abnormality and volunteer through Rally.

Exclusion

Who are over 75 years of age or older
With a history or current diagnosis of colonic and/or anal strictures
With a current diagnosis of any bleeding disorders
Who currently use drugs that interfere with coagulation (excluding low-dose aspirin)
With a history or current diagnosis of colorectal cancer
With a history or current diagnosis of diverticulosis or diverticulitis
With any prior anorectal, colorectal, or colonic surgery
With a history of volvulus or torsion
Who are pregnant
With contraindications to bowel prep or colonoscopy
With severe acute inflammatory bowel disease
With large hemorrhoids or hemorrhoidal bleeding or banding

What this trial measures

  • Ability of the R-TCE capsule to acquire quality images of the lower GI tractImaging data is collected during the study procedure and analyzed within one year of collection.