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New treatment option for Crohn Disease
Official title Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
ClinicalTrials.gov ID: NCT07033208
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.