Colon PolypsNCT07365436
Imaging the Colon Using a Colonoscope Compatible Imaging Probe
A study testing Feasibility of using a CC-OCT probe to image the GI tract in people with Colon Polyps and Colonoscopy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colon Polyps, Colonoscopy
- What is being tested?
- Feasibility of using a CC-OCT probe to image the GI tract
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age or older
- Capable of giving informed consent
- Capable of following bowel prep instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Colon Polyps, Colonoscopy
- Being tested
- Feasibility of using a CC-OCT probe to image the GI tract
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Undergoing Colorectal Screening | Experimental | 250 adult participants undergoing colorectal screening will be enrolled at MGH. Receives: Device: Feasibility of using a CC-OCT probe to image the GI tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the CC-OCT to image the lower GI tract
Measured: Images are collected during the study procedure and analyzed within one year of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start3 Mar 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, M.D., PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365436
- Sponsor's protocol ID
- 2025P001541
- Other IDs
- 1R01CA280972-01A1
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes