Optical Imaging for Gastrointestinal Biopsy Analysis

This study is exploring a new way to look at biopsy samples (small tissue samples) from your gastrointestinal (GI) tract using an optical imaging device. The goal is to see if this device can help doctors better detect and diagnose GI diseases without destroying the biopsy tissue. You might be able to join if you are at least 18 years old and are already scheduled for an esophagoduodenoscopy (a procedure to look at your esophagus, stomach, and the first part of your small intestine) or a colonoscopy (a procedure to look at your large intestine) at Massachusetts General Hospital. The study will be considered successful if the images from the device are of good quality and show microscopic features that can be compared to standard pathology results. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.
What's involved
If you participate, up to three extra biopsy samples will be taken during your scheduled endoscopy procedure. These samples will then be imaged and analyzed for research purposes.
Compensation
Not stated in the trial record.
Follow-up
Imaging data will be analyzed within one year of collection, but no specific follow-up for participants is mentioned.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04565704

Optical Imaging of Gastrointestinal Biopsy Samples and Their Correlation With Histology

Enrolling by Invitation
NAAges 18+InterventionalDevice feasibility
Massachusetts General Hospital
~200 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:Biopsy imaged by Optical imaging device.

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Feasibility based on image quality and presence of microscopic features
Measured over Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Gastrointestinal Disease
Gastrointestinal Dysfunction

NCT04565704

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Guillermo Tearney, M.D, PhD. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Device Feasibility based on image quality and presence of microscopic featuresImaging data is collected during the procedure, and analyzed within 1 year of collection.

    The feasibility will be determined by at least one of the following parameters: 1) assessing image adequacy (resolution, contrast, etc.) qualitatively, 2) confirming that microscopic features observed in the images are also seen by correlative histopathology, 3) ability to develop preliminary criteria or algorithms based on image-histopathology matches.