Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07219537

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

Led by Massachusetts General Hospital · Updated on 2025-12-16

30

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

T

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 18 years of age or older
  • Are healthy or have a confirmed diagnosis of Lynch Syndrome
  • Are capable of giving informed consent
  • Are able to follow bowel preparation instructions
  • Had a colonoscopy 0-24 months prior that did not show any abnormalities or have no gastrointestinal symptoms and no known lower GI tract disease and volunteer through Rally
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

N

Nitasha Bhat, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

2

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