Evaluation of a device for monitoring arteriovenous fistula function
Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
This study is testing a new wearable device that uses voice technology to help people on hemodialysis keep track of how well their arteriovenous fistulas are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai 10th People's Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05531825 on ClinicalTrials.gov |
What this trial studies
This study evaluates the reliability, practicality, and safety of a wearable device designed to measure the function of arteriovenous fistulas using voice print technology. The device aims to provide real-time monitoring and feedback on the health status of arteriovenous fistula vessels, which are critical for patients undergoing hemodialysis. By utilizing advanced technologies such as PVDF piezoelectric membranes and NB-IoT/4G transmission, the study seeks to enhance the management of complications associated with arteriovenous fistulas, ultimately improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who are diagnosed with end-stage renal failure and are planning to undergo venous fistula surgery or maintenance hemodialysis.
Not a fit: Patients who are pregnant, lactating, or have serious mental illnesses such as bipolar disorder or schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve the monitoring and management of arteriovenous fistulas, leading to better health outcomes for dialysis patients.
How similar studies have performed: While this approach is innovative, similar studies focusing on wearable technology for health monitoring have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75. * Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis. * Sign the informed consent. Exclusion Criteria: * Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness. * Other circumstances deemed inappropriate by the researcher * Quit midway
Where this trial is running
Shanghai, Shanghai
- Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ai Peng, MD,PhD
- Email: pengai@tongji.edu.cn
- Phone: 86-21-66302524
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.