Thermal Probe for Inflammatory Bowel Disease

AC
Overseen ByAnita Chung
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a thermal probe to determine its effectiveness in detecting temperature changes in the colon's lining for individuals with inflammatory bowel disease (IBD), Crohn's disease, or ulcerative colitis (UC). The probe will measure temperature in real time during a standard colonoscopy. Suitable participants include adults diagnosed with IBD, Crohn's, or UC, as well as those undergoing routine colorectal cancer screening who can safely undergo a colonoscopy.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance diagnostic techniques for IBD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this thermal probe is safe for measuring temperature in the colonic mucosa?

Research has shown that using a thermal probe to check temperature in the colon is generally safe. Other studies have used this tool to monitor inflammation, and no major safety issues have been reported. Participants who underwent this procedure experienced no serious side effects directly linked to the probe. This indicates that the thermal probe is a safe method for detecting temperature changes in the colon. However, as with any medical procedure, minor discomfort or irritation may occur. Prospective participants should discuss any concerns with the study team before joining.12345

Why are researchers excited about this trial?

Researchers are excited about the Thermal Probe for inflammatory bowel disease because it offers a new way to manage conditions like Crohn's disease and ulcerative colitis. Unlike traditional treatments that rely on medications like corticosteroids or immunosuppressants, the Thermal Probe uses heat to potentially reduce inflammation directly. This method could provide relief without the side effects commonly associated with medication. Additionally, the probe might deliver faster results, offering a promising alternative for those who don't respond well to drugs.

What evidence suggests that this thermal probe is effective for detecting temperature rise in the colonic mucosa?

This trial will evaluate the use of a heat-sensing tool, the Thermal Probe, during colonoscopies. Research has shown that such tools can detect temperature changes in the gut's lining, potentially indicating inflammation related to conditions like Crohn's disease and ulcerative colitis. Studies have found that non-invasive tools, like these heat-sensing probes, are useful for monitoring these conditions. By measuring temperature in real-time, the probe could identify inflammation without requiring more invasive tests. This method might help doctors better understand and manage inflammatory bowel diseases. Participants in this trial will include those undergoing colorectal screening and those diagnosed with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis.16789

Who Is on the Research Team?

GT

Guillermo Tearney, M.D., PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with inflammatory bowel diseases like Crohn's disease, ulcerative colitis, or general colitis. Participants will already be undergoing a standard colonoscopy as part of their care.

Inclusion Criteria

I can follow the study's requirements.
I am 18 years old or older.
I am able to understand and agree to the study's procedures and risks.
See 2 more

Exclusion Criteria

Participants who are pregnant
I cannot have a colonoscopy due to recent severe health issues or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Colonoscopy with Thermal Probe

During the participant's standard of care colonoscopy, the thermal probe will be inserted into the colonoscope to measure temperature rise in the colonic mucosa.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Thermal Probe

Trial Overview

The study is testing the feasibility of using a thermal probe to measure temperature changes in the lining of the colon during a routine colonoscopy in patients with certain bowel diseases.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Undergoing Colorectal ScreeningExperimental Treatment1 Intervention
Group II: IBD, Crohn's Disease, and/or UCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials
69
Recruited
101,000+

Citations

Thermal Measurements of the Gut With a Colonoscope ...

Study Overview. The goal of this clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of ...

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This review focused on the current non-invasive methods in the diagnosis of IBD, exploring their possible implementation in the near future.

Physiological Data Collected From Wearable Devices ...

Wearable devices collect nearly continuous physiological metrics that can identify and predict inflammatory and symptomatic inflammatory bowel ...

Current Approaches for Monitoring of Patients with ...

Inflammatory bowel diseases (IBD) involve complex chronic conditions that lead to long-term and/or permanent damage if not treated effectively [1]. Ulcerative ...

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C-reactive protein level at 2 weeks following initiation of infliximab induction therapy predicts outcomes in patients with ulcerative colitis: ...

Thermal Probe for Inflammatory Bowel Disease

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 ...

Gut Feeling: Biomarkers and Biosensors' Potential in ...

Inflammatory Bowel Diseases (IBDs) are complex, multifactorial disorders with no known cure, necessitating lifelong care and often leading to surgical ...

Implantable Sensor Could Lead to Timelier Crohn's ...

Wireless sensors monitoring inflammation could prevent or limit damage to intestines. Temperature sensor warns of disease flareups, ...

Implantable Sensor Could Lead to Timelier Crohn's Treatment

A team of Northwestern University scientists has developed the first wireless, implantable temperature sensor to detect inflammatory flareups in patients with ...