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

Massachusetts General Hospital · with The Leona M. and Harry B. Helmsley Charitable Trust, Dana-Farber Cancer Institute · NCT07219537

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
March 27, 2023
Record last updated
December 16, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The investigators have developed an inexpensive tool to take pictures in the lower GI tract without sedation and to look for signs of disease. The tool is a capsule, about the size of a fish oil or multi-vitamin supplement, attached to a string. The capsule and string are connected to a motor to allow the capsule to advance up the participant's lower GI tract. The capsule will be inserted into the participant's lower GI tract and advance upward via a slow spiral motion. The capsule is connected to an imaging system that saves and displays the images in real time.

Being studied: Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract

Conditions: Lynch Syndrome; Crohn Disease; Inflammatory Bowel Diseases; Healthy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Nitasha Bhat, MD · 617-643-6092 · Tearneylabtrials@partners.org

Study contacts (from the official record)

  • Nitasha Bhat, M.D. · 617-643-6092 · Tearneylabtrials@partners.org
All healthy volunteers studies in Massachusetts →
A Study for Imaging the Lower Gastrointestinal Tract Using a… (NCT07219537) | Bored Studies