A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Feasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Dana-Farber Cancer Institute
Collaborator
Source ClinicalTrials.gov