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

ConditionsLynch Syndrome Crohn Disease Inflammatory Bowel Diseases Healthy

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: HealthyExperimental treatment 1 intervention

Group B: With DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Tolerability of the R-TCE Capsule in an unsedated participant

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.

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Dana-Farber Cancer Institute