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NCT07219537Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
20 Oct 2025
Start date
27 Mar 2023
Primary completion date
31 Dec 2027
Lead sponsor
Massachusetts General Hospital
NCT number
NCT07219537

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 27 Mar 2023 to the primary completion date, 31 Dec 2027
  • 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.

Prior treatment

  • Who currently use drugs that interfere with coagulation (excluding low-dose aspirin)
  • With any prior anorectal, colorectal, or colonic surgery

Other illness

  • With a current diagnosis of any bleeding disorders
  • With a history or current diagnosis of colorectal cancer
  • With a history of volvulus or torsion
  • With severe acute inflammatory bowel disease
  • With large hemorrhoids or hemorrhoidal bleeding or banding

Age

  • Who are over 75 years of age or older

Other

  • With a history or current diagnosis of colonic and/or anal strictures
  • With a history or current diagnosis of diverticulosis or diverticulitis
  • Who are pregnant
  • With contraindications to bowel prep or colonoscopy

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.