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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07219537
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Nitasha Bhat, MD
[email protected]
617-643-6092

Find similar trials in Boston, MA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Massachusetts General Hospital· Boston, MA

Related Studies