Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe

Mass General Brigham

Status: Not yet enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07352995

2025P000709

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

IBD, Crohn's Disease, and/or UC

Experimental group

Description:

10 adult participants currently diagnosed with inflammatory bowel disease (IBD), Crohn's disease, and/or ulcerative colitis (UC) will be enrolled at MGH

Treatment:

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

Undergoing Colorectal Screening

Experimental group

Description:

10 adult subjects undergoing colorectal cancer screening will be enrolled at MGH

Treatment:

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