Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Subject is 18 -75 years old - Subject is considered healthy, with no known illnesses - Subject can follow fasting requirements - Subject can follow bowel prep instructions - Subject can provide informed consent
Exclusion Criteria
- Subject is older than 75 years of age - Subject with current dysphagia or any swallowing disorder - Subject 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 - Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility - Subject with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding - Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months - Subject with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs) - Subjects with a known contradiction to metoclopramide - Subjects with a known contraindication to polyethylene glycol - Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia - Subject who has had intestinal surgery in the past - Subject with a history of congestive heart failure - Subject with Type I or Type II Diabetes - Subject has a cardiac pacemaker or other implanted electromedical device. - Subject expected to undergo MRI examination within 7 days after ingestion of the capsule. - Subject 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 - Subject with delayed gastric emptying - Subject who is pregnant, suspected pregnant, or is actively breast-feeding.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Healthy Volunteers |
10 healthy adult subjects with no pre-existing gastrointestinal disorders will be enrolled at MGH |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
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. Subjects will be asked to do a standard of care bowel prep with instructions to start the prep three days before their scheduled procedure. Subjects may also be asked to fast for several hours and consume a series of laxative prep mixtures. Subject 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 subject 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 subject 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 subject will be asked to stay for up to 16 hrs or until the capsule has been passed, which ever is earlier. Should the subject 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 subject 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 subject 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 subject until the capsule has passed, and the subject 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 subject may be asked to return to MGH for medical intervention.