NCT07219537

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lynch Syndrome
• Crohn Disease
• Inflammatory Bowel Diseases
• Healthy

Interventions

Type	Name	Description
DEVICE	Feasibility 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.

Timeline

• Start date: 2023-03-27
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-10-22
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study