Imaging the Colon Using a Colonoscope Compatible Imaging Probe

January 22, 2026 updated by: Guillermo Tearney, Massachusetts General Hospital

Study for Imaging the Lower Gastrointestinal Tract Using a Colonoscopy-Compatible OCT Probe

The goal of this study is to use a colonoscope compatible device capable of taking images of the lower gastrointestinal tract. The main question it aims to answer is:

Is the colonoscope compatible optical coherence tomography probe (CC-OCT probe) an effective device to use to take images of the gut?

During the participant's standard of care colonoscopy, the CC-OCT probe will be inserted into the colonoscope. The CC-OCT probe will then collect images of the participant's gastrointestinal tract in real time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 45 years of age or older
  • Capable of giving informed consent
  • Capable of following bowel prep instructions

Exclusion Criteria:

  • 75 years of age or older
  • Any contraindication to bowel prep or colonoscopy
  • Current diagnosis of any bleeding disorders
  • Currently using drugs that interfere with coagulation (excluding low-dose aspirin)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Undergoing Colorectal Screening
250 adult participants undergoing colorectal screening will be enrolled at MGH.
Device: Feasibility of using a CC-OCT probe to image the GI tract
250 participants will be enrolled in this study. All consented participants will receive the same intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability of the CC-OCT to image the lower GI tract
Time Frame: Images are collected during the study procedure and analyzed within one year of collection
Images are collected during the study procedure and analyzed within one year of collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Guillermo Tearney, M.D., PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P001541
  • 1R01CA280972-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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