A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Recruiting now · Not applicable
Conditions studied: Lynch Syndrome, Crohn Disease, Inflammatory Bowel Diseases, Healthy
In brief
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.
Key facts
- Study ID
- NCT07219537
- Run by
- Massachusetts General Hospital
- People needed
- 30
- Starts
- 2023-03-27
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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