Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
Not applicable · Testing Feasibility to obtain thermal variance measurements using a wireless thermal capsule · 1 site · Massachusetts General Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Feasibility to obtain thermal variance measurements using a wireless thermal capsule (a device) to check whether a device is practical to use. Condition(s) listed: Crohn Disease, Inflammatory Bowel Diseases and Healthy.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 25 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-06-03.
- Main results expected around 2027-04-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Healthy Volunteers (listed as: experimental group)
Main thing being measured
- Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule (2 weeks)
In the researchers’ words
The goal of this research is to learn how a new device called the wireless thermal capsule (WTC) can collect thermal data to help see diseases that happen in the gastrointestinal (GI) tract, such as Crohn's Disease.
Words you might see
- Colonoscopy: a camera exam of the large intestine (colon).
- Endoscopy: a camera exam inside the digestive tract.
- Fistula: an abnormal tunnel between two parts of the body, which can happen in Crohn's disease.
- Stricture: a narrowing (of the bowel or of a bile duct).
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Inflammatory Bowel Diseases; Healthy |
| Lead sponsor | Massachusetts General Hospital |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 25 (estimated) |
| Start date | 2025-06-03 |
| Primary completion (est.) | 2027-04-30 |
| First posted | 2025-06-24 |
| Last updated | 2026-10-02 |
| Official title | Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance |
| ClinicalTrials.gov ID | NCT07033208 |
Interventions
- Feasibility to obtain thermal variance measurements using a wireless thermal capsule (Device)
A total of 25 healthy participants will be enrolled in this study all consented participants will receive the same intervention.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Criteria: * 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.