Wireless Thermal Capsule for Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the wireless thermal capsule (WTC) to evaluate its effectiveness in collecting temperature data from the digestive system, specifically for conditions like Crohn's Disease. The goal is to enhance doctors' ability to detect and understand gastrointestinal (GI) issues. The trial seeks healthy volunteers without any GI disorders. Participants should be comfortable with fasting and following bowel preparation instructions. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve diagnostic tools for GI conditions.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you use nonsteroidal anti-inflammatory drugs (NSAIDs) regularly, you may not be eligible to participate.
What prior data suggests that the wireless thermal capsule is safe for use in the gastrointestinal tract?
Research has shown that the wireless thermal capsule (WTC) is generally safe. Previous studies have focused on its ability to collect temperature data from the digestive system and have not reported any major side effects. For example, one study found that the WTC could gather temperature data effectively without causing harm, suggesting that people tolerate the capsule well. Since the trial phase isn't specified, it's important to note that early trials mainly test safety. This usually indicates that if the trial is ongoing, no major safety concerns have arisen so far.12345
Why are researchers excited about this trial?
The Wireless Thermal Capsule is unique because it introduces a new way to manage Crohn's Disease by using heat therapy delivered wirelessly. Unlike traditional treatments that often involve medications like immunosuppressants or biologics to control inflammation, this capsule offers a non-drug alternative that targets the gut directly with thermal energy. Researchers are excited because this approach could reduce the reliance on systemic medications, potentially minimizing side effects and offering a novel, localized treatment option for patients.
What evidence suggests that the wireless thermal capsule is effective for Crohn's Disease?
Studies have shown that wireless capsule endoscopy, including the wireless thermal capsule in this trial, is a promising tool for diagnosing and assessing Crohn's Disease. This device is less invasive and may offer greater accuracy than traditional methods. It provides a clearer view of the digestive tract, aiding in earlier problem identification. Research suggests that capsule endoscopy can assess disease severity and might enhance early diagnosis. Although limited data exist on the wireless thermal capsule's effectiveness in treating Crohn's Disease, its capability to gather detailed temperature information offers a new way to better understand this condition.56789
Who Is on the Research Team?
Guillermo Tearney, MD, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with Crohn's Disease or Inflammatory Bowel Disease, as well as healthy volunteers. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants perform a standard bowel prep and may fast for several hours before the procedure
Procedure
Participants swallow the wireless thermal capsule and are monitored for up to 16 hours or until the capsule is passed
Follow-up
Participants are monitored until the capsule is passed, with potential follow-up at home or return to MGH if necessary
What Are the Treatments Tested in This Trial?
Interventions
- Wireless Thermal Capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator