Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe

NCT07352995 | Enrolling By Invitation FDA Device

• 1 other identifier: 2025P000709
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Ability of thermal probe to collect temperature measurements from colonic mucosa

  Thermal measurements are collected during the study procedure and analyzed within one year of collection.

Study Arms (2)

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

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

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

Interventions

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.

IBD, Crohn's Disease, and/or UC; Undergoing Colorectal Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Guillermo Tearney, M.D., PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All study participants will get the same intervention

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)