Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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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