Wireless thermal capsule to detect gastrointestinal temperature changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intestinal ultrasound-guided management for inflammatory bowel disease

  This study tests if adding point-of-care intestinal ultrasound at every visit changes treatment decisions for adults with Crohn’s disease or ulcerative colitis undergoing disease assessment.

  Recruiting Mahidol University · Bangkok · NCT07775352

• Self-management program to improve health in inflammatory bowel disease

  A digital self-management program is being tested to see if it helps people with inflammatory bowel disease feel better and manage their symptoms alongside standard care.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07456566

• Lower GI imaging with a tethered camera capsule

  This test tries a small camera capsule on a string that takes pictures of the lower gut without sedation for adults who are healthy or who have Lynch syndrome, Crohn's disease, or other inflammatory bowel diseases.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07219537

• COMPARE — Newer IBD treatments in children

  This project compares the safety and effectiveness of newer IBD medicines for children with Crohn's disease or ulcerative colitis who did not respond to anti‑TNF treatment.

  Recruiting at 4 sites University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 3 other locations · NCT07198113

• Examining the link between polyamine levels and inflammatory bowel disease progression

  This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT06995170

• Observational study comparing inflammatory markers in IBD and non-IBD participants

  This study is trying to see how inflammation levels in people with Crohn's Disease and Ulcerative Colitis compare to those without these conditions when they start new treatments.

  Recruiting University of Nottingham · Nottingham, Nottinghamshire · NCT06956703

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.