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

Mass General Brigham

Status: Enrolling

Conditions: Healthy; Lynch Syndrome; Inflammatory Bowel Diseases; Crohn Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07219537

2022P001154

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Healthy

Experimental group

Description:

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

Treatment:

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

With Disease

Experimental group

Description:

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

Treatment:

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