Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe

N/AEnrolling By InvitationNCT07352995

Massachusetts General Hospital20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.