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

Not Applicable

Recruiting

• Conditions: Lynch Syndrome; Crohn Disease; Inflammatory Bowel Diseases; Healthy

• Registration Number: NCT07219537
• Lead Sponsor: Massachusetts General Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-22
• Last Update Posted: 2025-10-22
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability of the R-TCE Capsule in an unsedated participant	45 minutes during the study visit	R-TCE imaging will be conducted in unsedated participants. The study team will ask the participants about their comfort level throughout the procedure. Participants will be asked to score the tolerability of the procedure using a scoring system from 0 to 10. With 0 being the most tolerable to10 being the least.
Ability of the R-TCE capsule to acquire quality images of the lower GI tract	Imaging data is collected during the study procedure and analyzed within one year of collection.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States