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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Nitasha Bhat, M.D.
Tearneylabtrials@partners.org
617-643-6092
Time Frame
Start Date: 2023-03-27
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Healthy
20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.
Experimental: With Disease
10 adult participants with a confirmed diagnosis of Lynch Syndrome, Crohn's Disease, or Inflammatory Bowel Disease will be enrolled at MGH.
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Dana-Farber Cancer Institute
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov