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NCT Number: NCT07219537

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

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.

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Key information

Conditions

Lynch Syndrome Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crohn Disease DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Healthy Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Nitasha Bhat, MD

CONTACT

[email protected]

617-643-6092

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tolerability of the R-TCE Capsule in an unsedated participant

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nitasha Bhat, M.D.

CONTACT

[email protected]

617-643-6092

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 22, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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