Using a new device to improve drainage of fluid from the body
Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study
This study is testing a new device called Effidrain to see if it can help people with fluid buildup in their bodies drain fluids more effectively and reduce the time they need to have drains in place.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Changi General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05734729 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to validate the Effidrain, a programmable drain fluid regulator, for patients suffering from pleural effusions and ascites. The study will involve 120 participants and will assess the device's ability to accurately and precisely drain body fluids while reducing the time patients need to have drains in place. Additionally, it will evaluate the impact of Effidrain on healthcare workers' time and the overall cost-effectiveness of the intervention compared to conventional drainage methods.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with significant pleural effusions or ascites requiring drainage.
Not a fit: Patients with unstable hemodynamics or complex drainage needs may not benefit from this device.
Why it matters
Potential benefit: If successful, this device could significantly improve patient outcomes and reduce the burden of care associated with fluid drainage.
How similar studies have performed: While this approach is novel, similar studies on advanced drainage technologies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pleural effusion or ascites as the primary indication for chest or abdominal drain insertion * Expected ascites drainage volume more than 1 Litre or at least moderate sized pleural effusion (occupying more than one-third hemi-thorax) * uncomplicated chest or abdominal drain insertion * Adults aged 21 years, able to provide (or surrogate able to provide) consent. Exclusion Criteria: * Vulnerable persons, including but not limited to, pregnant women and prisoners * Hemodynamic instability, defined by heart rate more than 120 beats per minutes and blood pressure less than systolic 90mmHg * Haemothorax or Haemoperitoneum * pneumothorax or pneumoperitoneum * chest or abdominal drain insertion =\> 48 hours with more than estimated 50% of total body cavity fluid drained
Where this trial is running
Singapore
- Changi General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Jessica Quah Lishan
- Email: jessica.quah.l.s@singhealth.com.sg
- Phone: 9679 7074
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.