A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Recruiting · NCT07219537 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
What this trial is 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States