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

Mass General Brigham

Status

Enrolling

Conditions

Healthy

Inflammatory Bowel Diseases

Crohn Disease

Treatments

Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT07033208

2023P002565

Details and patient eligibility

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.