Status:
RECRUITING
A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Dana-Farber Cancer Institute
Conditions:
Lynch Syndrome
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 mu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07219537
Start Date
March 27 2023
End Date
December 31 2028
Last Update
December 16 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114