Evaluating a smart capsule for monitoring intra-abdominal pressure
Evaluating Effectiveness of Elevated Intra-abdominal Pressure (IAP) by PressureDOT.
This study is testing a new smart capsule that can safely and easily monitor pressure in the abdomen to see if it works better than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 20 Months to 65 Months |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06709924 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of the PressureDOT, a real-time pressure-sensing smart capsule designed to monitor elevated intra-abdominal pressure. Unlike traditional methods that require invasive procedures, the PDT capsule offers a minimally invasive and wireless solution, aiming to reduce risks such as urinary tract infections. The study will involve healthy participants without prior abdominal surgeries, and it will assess the capsule's ability to continuously monitor pressure and temperature while transmitting data. The goal is to establish a new standard for monitoring intra-abdominal pressure.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals without any previous abdominal surgical history.
Not a fit: Patients with a history of abdominal surgeries or gastrointestinal obstructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more efficient method for monitoring intra-abdominal pressure in patients.
How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success, as this method appears to be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy participants without previous surgical history Exclusion Criteria: * previous abdominal surgical history * GI obstruction history * no need of magnetic resonance imaging in two weeks after capsule ingestion. * history of swallowing difficulty, dysphagia, odynophagia.
Where this trial is running
Taichung
- China Medical University &Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Henry Liu, MS
- Email: vulbjobjo@gmail.com
- Phone: 0963048589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.