NCT07365436

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Mar 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Dec 2029

First Submitted

Initial submission to the registry

January 13, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

January 13, 2026

Last Update Submit

January 22, 2026

Conditions

Colon PolypsColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Ability of the CC-OCT to image the lower GI tract

    Images are collected during the study procedure and analyzed within one year of collection

Study Arms (1)

Undergoing Colorectal Screening

EXPERIMENTAL

250 adult participants undergoing colorectal screening will be enrolled at MGH.

Device: Feasibility of using a CC-OCT probe to image the GI tract

Interventions

Feasibility of using a CC-OCT probe to image the GI tractDEVICE

250 participants will be enrolled in this study. All consented participants will receive the same intervention.

Undergoing Colorectal Screening

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guillermo Tearney, M.D., PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitasha Bhat, M.D.

CONTACT

617-643-6092Tearneylabtrials@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 26, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

January 26, 2026

Record last verified: 2026-01