Recruiting

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

Sponsor:

Massachusetts General Hospital

Code:

NCT07219537

Conditions

Lynch Syndrome

Crohn Disease

Inflammatory Bowel Diseases

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract

Study Details

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.

Conditions

Lynch Syndrome

Crohn Disease

Inflammatory Bowel Diseases

Healthy

Study ID

NCT07219537

Start date

Mar 27, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Healthy

20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.

experimental: With Disease

10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH.

Interventions

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.

Primary outcome measure

Ability of the R-TCE capsule to acquire quality images of the lower GI tract [ Time Frame: Imaging data is collected during the study procedure and analyzed within one year of collection. ]

Central Contacts and Locations

Central contacts

Nitasha Bhat, M.D.

617-643-6092 Tearneylabtrials@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Nitasha Bhat, MD

617-643-6092 Tearneylabtrials@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-16.