Actively Recruiting
Pilot 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
52 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
Researchers are evaluating a new, low-cost imaging tool that captures pictures of the lower gastrointestinal (GI) tract without the need for sedation. This device is a capsule about the size of a fish oil or multi-vitamin supplement, attached to a string and connected to a motor. The study includes healthy adults and adults diagnosed with Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease, aiming to assess the device's ability to capture quality images of the lower GI tract. The tool, called the Retrograde Tethered Capsule Endomicroscope (R-TCE) device, is inserted into the participant's lower GI tract and moves upward through a slow spiral motion controlled by the motor. The capsule is connected to an imaging system that saves and displays images in real time. The study will enroll 30 participants who will all receive this same intervention. Participants are grouped into healthy adults and adults with specific gastrointestinal conditions. During the study, the device's image quality and tolerability will be assessed, including participants' experiences without sedation. Imaging data will be collected during the procedure and analyzed within one year. Participants will follow bowel preparation instructions before the procedure. The study will monitor for any adverse effects and evaluate how well the capsule is tolerated on the day of the procedure. Total participation time varies with individual schedules.
CONDITIONS
Brief 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 prep instructions
- Had a colonoscopy 0-24 months prior that showed no abnormalities or report no gastrointestinal symptoms and no known lower GI disease
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 prep 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the procedure using the Retrograde Tethered Capsule Endomicroscope device to image the lower gastrointestinal tract.
1 visit (in-person)
Duration - 1 day
Participants are monitored for tolerability and any immediate effects following the procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
N
Nitasha Bhat, M.D.
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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