Inflammatory Bowel DiseasesNCT07352995
Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe
A study testing Feasibility of using a thermal probe to measure temperature rise in colonic mucosa in people with Inflammatory Bowel Diseases and Crohn Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of participants with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Feasibility of using a thermal probe to measure temperature rise in colonic mucosa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 18 years or older
- Participants undergoing elective colonoscopy
- Participants capable of following requirements
- Participants capable of providing informed consent
- Participants with a diagnosis of IBD, Crohn's disease, and/or ulcerative colitis or participants undergoing colorectal cancer screening
Who cannot join
- Participants contraindicated for colonoscopy, including experiencing acute events within the last 6 weeks prior to the colonoscopy (i.e. subjects suffering from a myocardial infarction (heart attack), diagnosis of peritonitis (the inflammation of the membrane lining of the abdominal wall), diagnosis of hemodynamic instability (shock), surgery involving colonic anastomosis (reconnection of the colon), and/or bowel injury (from trauma or surgery)
- Participants who are pregnant
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: Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD
The goal of this clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of participants with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis. The main question it aims to answer is:
Is the thermal probe an effective device to use to detect temperature rise in the colonic mucosa?
During the participant's standard of care colonoscopy, the thermal probe will be inserted into the colonoscope. The thermal probe is connected to a temperature transmitter that collects and saves the temperature of the colon in real time.
- Being tested
- Feasibility of using a thermal probe to measure temperature rise in colonic mucosa
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of using a thermal probe to measure temperature rise in colonic mucosaDevice
10 participants in each arm will be enrolled in this study. All consented participants will receive the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| IBD, Crohn's Disease, and/or UC | Experimental | 10 adult participants currently diagnosed with inflammatory bowel disease (IBD), Crohn's disease, and/or ulcerative colitis (UC) will be enrolled at MGH Receives: Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa |
| Undergoing Colorectal Screening | Experimental | 10 adult subjects undergoing colorectal cancer screening will be enrolled at MGH Receives: Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of thermal probe to collect temperature measurements from colonic mucosa
Measured: Thermal measurements 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 posted20 Jan 2026
- Study start25 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 Inflammatory Bowel DiseasesStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All study participants will get the same intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- 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
- NCT07352995
- Sponsor's protocol ID
- 2025P000709
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD
- ClinicalTrials.gov ID
- NCT07352995
- Acronym / sponsor ID
- 2025P000709
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 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 clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of participants with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis. The main question it aims to answer is:
Is the thermal probe an effective device to use to detect temperature rise in the colonic mucosa?
During the participant's standard of care colonoscopy, the thermal probe will be inserted into the colonoscope. The thermal probe is connected to a temperature transmitter that collects and saves the temperature of the colon in real time.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All study participants will get the same intervention
| Arm | Type | Receives |
|---|---|---|
| IBD, Crohn's Disease, and/or UC | Experimental | Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa10 adult participants currently diagnosed with inflammatory bowel disease (IBD), Crohn's disease, and/or ulcerative colitis (UC) will be enrolled at MGH |
| Undergoing Colorectal Screening | Experimental | Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa10 adult subjects undergoing colorectal cancer screening will be enrolled at MGH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants 18 years or older
- Participants undergoing elective colonoscopy
- Participants capable of following requirements
- Participants capable of providing informed consent
- Participants with a diagnosis of IBD, Crohn's disease, and/or ulcerative colitis or participants undergoing colorectal cancer screening
Key exclusion criteria (2 listed)
- Participants contraindicated for colonoscopy, including experiencing acute events within the last 6 weeks prior to the colonoscopy (i.e. subjects suffering from a myocardial infarction (heart attack), diagnosis of peritonitis (the inflammation of the membrane lining of the abdominal wall), diagnosis of hemodynamic instability (shock), surgery involving colonic anastomosis (reconnection of the colon), and/or bowel injury (from trauma or surgery)
- Participants who are pregnant
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 thermal probe to measure temperature rise in colonic mucosa10 participants in each arm will be enrolled in this study. All consented participants will receive the same intervention. | Device | IBD, Crohn's Disease, and/or UC, Undergoing Colorectal Screening |
Primary outcome
Ability of thermal probe to collect temperature measurements from colonic mucosa
Time frame: Thermal measurements 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 20 Apr 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 thermal probe to measure temperature rise in colonic mucosa in people with Inflammatory Bowel Diseases and Crohn Disease, 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 5 inclusion and 2 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 20 Apr 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 thermal probe to collect temperature measurements from colonic mucosa (time frame: Thermal measurements 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 20 Apr 2026.