Crohn Disease, Healthy, Inflammatory Bowel Diseases, Lynch Syndrome
Conditions
Brief 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.
Interventions
DEVICEFeasibility of using an OCT-based Retrograde Tethered Capsule Endomicroscope device to image the lower GI tract
30 participants will be enrolled in this study. All consented participants will receive the same intervention.
Sponsors
The Leona M. and Harry B. Helmsley Charitable Trust
Dana-Farber Cancer Institute
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of the R-TCE capsule to acquire quality images of the lower GI tract | Imaging data is collected during the study procedure and analyzed within one year of collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of the R-TCE Capsule in an unsedated participant | Day 1 | 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. |
Countries
United States
Contacts
Primary ContactNitasha Bhat, M.D.
Outcome results
None listed