Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05531825

Enrollment

200

Registered

2022-09-08

Start date

2022-05-01

Completion date

2025-12-31

Last updated

2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula Flow Monitoring, Early Detection of Complications of Arteriovenous Fistula, Voiceprint

Brief summary

Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.

Detailed description

Arteriovenous fistula is the lifeline of maintenance hemodialysis patients. At present, there is a lack of a simple wearable real-time evaluation technology and device for arteriovenous fistula, which can help doctors find and deal with the complications of arteriovenous fistula timely and accurately. This study proposes an innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels, so that the use time of arteriovenous fistula can be prolonged and the survival rate of dialysis patients can also be improved.

Interventions

DEVICEA device for detecting arteriovenous fistula vascular function

An innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula	2 month	Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

Countries

China

Contacts

Primary ContactAi Peng, MD,PhD

pengai@tongji.edu.cn86-21-66302524

Backup ContactDayong Hu

shiyuanhudayong@sina.com86-21-66302527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026