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OpenTrials
Enrolling by Invitation

NCT Number: NCT07352995

Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe

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.

Enrolling by Invitation

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feasibility of using a thermal probe to measure temperature rise in colonic mucosa

Device

10 participants in each arm will be enrolled in this study. All consented participants will receive the same intervention.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study title

Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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