RecruitingNot ApplicableNCT07219537

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


Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of capsule called the Retro-TCE capsule for imaging the lower gastrointestinal (GI) tract — the colon and rectum. Instead of a traditional colonoscopy where a doctor inserts a camera, this capsule is swallowed (or administered via an enema-like approach) and travels through the bowel taking pictures. **You may be eligible if...** - You are between 18 and 75 years old - You are generally healthy OR have a confirmed diagnosis of Lynch Syndrome (a genetic condition increasing colon cancer risk) - You had a normal colonoscopy within the past 24 months OR you report no GI symptoms or known bowel problems - You are able to follow bowel preparation instructions **You may NOT be eligible if...** - You are over 75 years old - You have had colorectal cancer, diverticulosis, diverticulitis, or previous bowel surgery - You have anal or colon strictures (narrowings) - You have bleeding disorders or take blood thinners (other than low-dose aspirin) - You are pregnant - You have severe inflammatory bowel disease or large hemorrhoids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFeasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract

30 participants will be enrolled in this study. All consented participants will receive the same intervention.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07219537


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