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

Recruiting now · Not applicable

Conditions studied: Crohn Disease, Inflammatory Bowel Diseases, Healthy

In brief

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.

Key facts

Study ID

NCT07033208

Run by

Massachusetts General Hospital

People needed

10

Starts

2025-06-03

Expected to finish

2027-04-30

Last updated by the study team

2025-10-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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