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

NCT07219537 | Recruiting FDA Device

• 1 other identifier: 2022P001154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Crohn Disease; Healthy; Lynch Syndrome; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Tolerability of the R-TCE Capsule in an unsedated participant

  Day 1

Study Arms (2)

Healthy

EXPERIMENTAL

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

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

With Disease

EXPERIMENTAL

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

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

Interventions

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

30 participants will be enrolled in this study. All consented participants will receive the same intervention.

Healthy; With Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis

Study Officials

• Guillermo Tearney, M.D., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitasha Bhat, M.D.

CONTACT

617-643-6092; Tearneylabtrials@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: March 27, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)