RecruitingNot ApplicableNCT07033208

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


Sponsor

Massachusetts General Hospital

Enrollment

10 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria18

  • 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.

Interventions

DEVICEFeasibility to obtain thermal variance measurements using a wireless thermal capsule

A total of 10 healthy participants will be enrolled in this study all consented participants will receive the same intervention.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07033208


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