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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, small device called a wireless thermal capsule, which is swallowed like a pill. This capsule travels through the digestive system and measures temperature changes inside the gastrointestinal (GI) tract, which includes the stomach and intestines. The goal is to see if this device can help detect conditions like Crohn’s Disease, a type of inflammatory bowel disease that affects the digestive tract.

Adults between 18 and 75 years old who are generally healthy and can follow specific instructions about fasting and bowel preparation may be eligible to join. Participants will swallow the capsule and allow it to pass naturally while the device collects temperature data. It’s important to note that people with certain health issues—such as swallowing problems, bowel blockages, or heart conditions—are not eligible. This study is still recruiting volunteers, and those interested should be able to give informed consent and follow the study’s guidelines. The trial is designed to be safe and aims to learn if this new technology can improve how digestive diseases are detected in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is 18 -75 years old
• • Subject is considered healthy, with no known illnesses
• • Subject can follow fasting requirements
• • Subject can follow bowel prep instructions
• • Subject can provide informed consent
• Exclusion Criteria:
• • Subject is older than 75 years of age
• • Subject with current dysphagia or any swallowing disorder
• • Subject 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
• • Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility
• • Subject with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding
• • Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months
• • Subject with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)
• • Subjects with a known contradiction to metoclopramide
• • Subjects with a known contraindication to polyethylene glycol
• • Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia
• • Subject who has had intestinal surgery in the past
• • Subject with a history of congestive heart failure
• • Subject with Type I or Type II Diabetes
• • Subject has a cardiac pacemaker or other implanted electromedical device.
• • Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
• • Subject 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
• • Subject with delayed gastric emptying
• • Subject who is pregnant, suspected pregnant, or is actively breast-feeding.