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

NCT ID: NCT07033208

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2027-04-30

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.

Detailed Description

The purpose of this study is to determine the feasibility of using the wireless thermal capsule (WTC) to collect temperature information from the human GI tract in healthy adult subjects. Participants will be asked to do a standard of care bowel prep with instructions to start the prep three days before their scheduled procedure. Participants may also be asked to fast for several hours and consume a series of laxative prep mixtures. Participants will be given a bed to sit in the Translational and Clinical Research Center at MGH. After informed consent, a receiver belt and 8 antennas will be placed on the subjects abdomen by trained study staff. The participant will be asked to swallow the WTC capsule, and will have 10 attempts to try to swallow the capsule. They may be also offered optional swallowing aids such as PillGlide or Chloraseptic to help swallow the capsule. If the participant is not able to swallow the capsule after 10 attempts, the research procedure will be terminated. Once the WTC has been swallowed, the research study team will monitor the subject hourly and collect thermal and position tracking data from the WTC as it travels the GI tract and is excreted in their stools. The participant will be asked to stay for up to 16 hrs or until the capsule has been passed, which ever is earlier. Should the participant experience any new symptoms that could indicate a problem in the GI tract, (abdominal discomfort, blood in stool, nausea), a physician will be consulted. The participant may be asked to consume drugs such as metoclopramide or polyethylene glycol to help move the capsule along in their gut. If the capsule hasn't been passed after 16 hours, the participant may be cleared to return home if they have no other symptoms, and may be asked to self monitor until the capsule has passed. The study team will follow up with the participant until the capsule has passed, and the participant may be asked to provide visual confirmation that the capsule has been successfully passed at home. If passage is not confirmed after 2 weeks, the participant may be asked to return to MGH for medical intervention.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

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

Group Type: EXPERIMENTAL

Feasibility to obtain thermal variance measurements using a wireless thermal capsule

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Tearney

Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Tearney, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anita Chung

Role: CONTACT

tearneylabtrials@partners.org

6177244515

Facility Contacts

Anita Chung

Role: primary

tearneylabtrials@partners.org

6177244515

Other Identifiers

2023P002565

Identifier Type: -

Identifier Source: org_study_id