Recruiting

Wireless Thermal Capsule

Sponsor:

Massachusetts General Hospital

Code:

NCT07033208

Conditions

Crohn Disease

Inflammatory Bowel Diseases

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Feasibility to obtain thermal variance measurements using a wireless thermal capsule

Study Details

Brief 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.

Conditions

Crohn Disease

Inflammatory Bowel Diseases

Healthy

Study ID

NCT07033208

Start date

Jun 3, 2025

Status verified date

Oct, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

10 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH

Interventions

Feasibility 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.

Primary outcome measure

  • Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Anita Chung

6177244515tearneylabtrials@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Anita Chung

6177244515tearneylabtrials@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 22, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-22.