Actively Recruiting
Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
Led by Massachusetts General Hospital · Updated on 2025-10-22
10
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Anita Chung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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