Imaging the Colon Using a Colonoscope Compatible Imaging... | NCT07365436

Studies
Imaging the Colon Using a Colonoscope Compatible Imaging Probe

NCT07365436

Sponsor

Massachusetts General Hospital

Status

Not yet recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Colon Polyps
Colonoscopy

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01CA280972-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Jan 13, 2026

First Submission Date that Met QC Criteria

Jan 22, 2026

First Posted Date

Jan 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Feasibility of using a CC-OCT probe to image the GI tract	Device	250 participants will be enrolled in this study. All consented participants will receive the same intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nitasha Bhat, M.D.	Contact	617-643-6092		Tearneylabtrials@partners.org

Overall Officials

Name	Affiliation	Role
Guillermo Tearney, M.D., PhD	Massachusetts General Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided