Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04565704
Status
Enrolling By Invitation

Conditions

  • Gastrointestinal Disease
  • Gastrointestinal Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Biopsy imaged by Optical imaging device. — DEVICE

Study Details

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

Key Dates

Start date
Mar 25, 2016
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Development of novel optical imaging technologies
    Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.

Primary Outcome Measure

Device Feasibility based on image quality and presence of microscopic features [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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