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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy 		20 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH.
  • Device: Feasibility 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.
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.
  • Device: Feasibility 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.

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Nitasha Bhat, MD
617-643-6092
Tearneylabtrials@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Nitasha Bhat, M.D.
617-643-6092
Tearneylabtrials@partners.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.