Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07033208

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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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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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