Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD
Overview
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.
Interventions
- Device Feasibility of using a thermal probe to measure temperature rise in colonic mucosa
10 participants in each arm will be enrolled in this study. All consented participants will receive the same intervention.
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07352995 · 2025P000709