Feasibility of a Wireless Thermal Capsule Endoscopy

This study is looking at how well a new device, called the wireless thermal capsule (WTC), can measure temperature changes in your digestive system (gastrointestinal or GI tract). Researchers want to see if these temperature measurements can help detect diseases like Crohn's Disease. They are testing the WTC in 10 healthy adults between 18 and 75 years old. To join, you need to be healthy, follow fasting rules, and complete bowel preparation instructions. The main goal is to measure the average temperature changes in your GI tract using the WTC over two weeks. The current status of this study is unclear.

Study design: This is an interventional study with 10 healthy participants. All participants will receive the same intervention, which involves swallowing the wireless thermal capsule.
What's involved: You will need to follow fasting and bowel preparation instructions before the procedure. You will swallow the wireless thermal capsule and stay at the research center for up to 16 hours or until the capsule passes.
Compensation: Not stated in the trial record.
Follow-up: The primary measurement of gastrointestinal temperature variance will be taken at 2 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

Recruiting

NAAges 18–75InterventionalDevice feasibility

Massachusetts General Hospital

~10 participants

Updated 2025-10-22 on ClinicalTrials.gov

What's tested:Feasibility to obtain thermal variance measurements using a wireless thermal capsule

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule

Measured over 2 weeks

Conditions

Crohn Disease

Inflammatory Bowel Diseases

Healthy

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Guillermo Tearney, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Anita Chung

[email protected]

6177244515

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Participant is 18 -75 years old

Participant is considered healthy, with no known illnesses

Participant can follow fasting requirements

Participant can follow bowel prep instructions

Participant can provide informed consent

Exclusion

Participant is older than 75 years of age

Participant with current dysphagia or any swallowing disorder

Participant with any current condition believed to have an increased risk of capsule retention such as gastrointestinal strictures, intestinal tumors, bowel obstruction, incomplete colonoscopies or fistula

Participant with a diagnosis of gastroparesis or small bowel or large bowel dysmotility

Participant with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding

Participant with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months

Participant with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)

Participants with a known contradiction to metoclopramide

Participants with a known contraindication to polyethylene glycol

Participant with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia

Participant who has had intestinal surgery in the past

Participant with a history of congestive heart failure

Participant with Type I or Type II Diabetes

Participant has a cardiac pacemaker or other implanted electromedical device.

Participant expected to undergo MRI examination within 7 days after ingestion of the capsule.

Participant has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study

Participant with delayed gastric emptying

Participant who is pregnant, suspected pregnant, or is actively breast-feeding.

What this trial measures

Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule2 weeks
This is a pilot study to demonstrate that the capsule can transmit valid temperature data from within the gastrointestinal tract. Since the study participants are nominally healthy, we anticipate that on a per patient basis, the capsule will detect a core body temperature with a mean variance (σ\^2) of +/- 0.5°C. With a study size of 10 participants, the measured mean variance 95% confidence intervals will be 0.24≤σ\^2≤1.6 °C, which is sufficient to demonstrate that the capsule transmits valid gastrointestinal tract temperature data.

Trialytics