Wireless thermal capsule to detect gastrointestinal temperature changes
Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
NA · Massachusetts General Hospital · NCT07033208
This study tests a swallowable wireless thermal capsule to see if it can collect temperature data from the GI tract in healthy adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07033208 on ClinicalTrials.gov |
What this trial studies
Healthy adult participants will complete a standard bowel prep beginning three days before the procedure and may fast for several hours on the day of testing. Trained staff will place a receiver belt with eight antennas on the participant's abdomen and the participant will attempt to swallow the wireless thermal capsule, with up to 10 attempts and optional swallowing aids. The team will monitor the participant hourly and collect thermal and position-tracking data as the capsule travels through and is excreted from the GI tract, with participants staying up to 16 hours or until passage. Study staff will consult a physician if participants develop concerning symptoms such as abdominal pain, bleeding, or nausea.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18–75 who can follow bowel prep and fasting instructions and who have no swallowing disorder or known risk for capsule retention.
Not a fit: People with active inflammatory bowel disease, known GI strictures, motility disorders, swallowing disorders, significant renal disease, or age over 75 are excluded and unlikely to benefit from this feasibility test.
Why it matters
Potential benefit: If successful, the device could provide a noninvasive way to map gut temperature patterns that might help detect or monitor conditions like Crohn's disease.
How similar studies have performed: Traditional capsule endoscopy is well established for imaging the GI tract, but using a wireless thermal capsule to record temperature variance is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Guillermo Tearney, MD, PhD — Massachusetts General Hospital
- Study coordinator: Anita Chung
- Email: tearneylabtrials@partners.org
- Phone: 6177244515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Inflammatory Bowel Diseases, Healthy