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Clinical Trials/NCT05531825
NCT05531825
Recruiting
N/A

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

Ai Peng1 site in 1 country200 target enrollmentMay 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arteriovenous Fistula Flow Monitoring
Sponsor
Ai Peng
Enrollment
200
Locations
1
Primary Endpoint
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
December 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ai Peng
Responsible Party
Sponsor Investigator
Principal Investigator

Ai Peng

Director of the Department of Nephrology

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

Time Frame: 2 month

Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

Study Sites (1)

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