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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Imaging the Lower Gastrointestinal Tract Using a Colonoscopy-Compatible OCT Probe
- ClinicalTrials.gov ID
- NCT07365436
- Acronym / sponsor ID
- 2025P001541
- Conditions
- Colon Polyps, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undergoing Colorectal Screening | Experimental | Device: Feasibility of using a CC-OCT probe to image the GI tract250 adult participants undergoing colorectal screening will be enrolled at MGH. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45 years of age or older
- Capable of giving informed consent
- Capable of following bowel prep instructions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility of using a CC-OCT probe to image the GI tract250 participants will be enrolled in this study. All consented participants will receive the same intervention. | Device | Undergoing Colorectal Screening |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Tearney, M.D., PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.