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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "This is a two visit study, during the first study visit, informed consent will be collected."
  • "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."
  • "A member of the study staff may communicate with the subject every few days until the subject has excreted the capsule in their stool or until 50 hours have passed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new device called a wireless thermal capsule (WTC). It collects temperature data from the digestive tract to help find diseases such as Crohn’s disease. The study is for healthy adults ages 18 to 75 with no known illnesses.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • You are healthy and have no known illnesses.
  • You can follow instructions about not eating before the test.
  • You can follow instructions to clean out your bowels.
  • You can give informed consent, meaning you understand the study and agree to join.

Who can't join

  • You have trouble swallowing or a condition that could make the capsule get stuck, such as a narrowed or blocked bowel, bowel tumors, an incomplete colonoscopy, or a fistula (an abnormal passage in the body).
  • Your stomach empties slowly, your bowels do not move food normally, or you have a history of inflammatory bowel disease, Crohn’s disease, or long-term constipation.
  • You have kidney disease, including important abnormal kidney test results in the past 6 months; a history of heart failure; or type 1 or type 2 diabetes.
  • You regularly use NSAIDs (anti-inflammatory pain medicines), or you cannot safely take metoclopramide or polyethylene glycol.
  • You have had bowel surgery or bleeding from the rectum, or you currently have suspected or confirmed blood in your stool, black tar-like stool, or low iron with or without anemia (too few healthy red blood cells).
  • You have a pacemaker or another implanted electrical medical device, or you expect to have an MRI scan within 7 days after swallowing the capsule.
  • You joined a drug or device research study within 30 days before enrollment that could affect your safety or ability to take part.
  • You are pregnant, may be pregnant, or are breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA