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

Ai Peng

Status

Enrolling

Conditions

Voiceprint

Arteriovenous Fistula Flow Monitoring

Early Detection of Complications of Arteriovenous Fistula

Treatments

Device: A device for detecting arteriovenous fistula vascular function

Study type

Observational

Funder types

Other

Identifiers

NCT05531825

SHSY-IEC-5.0/22K54/P01

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Normal control group

Description:

Patients with no disease in the main organs, with well-developed body shape, and with good physiological functions, physical activity abilities and labor abilities.

Treatment:

Device: A device for detecting arteriovenous fistula vascular function

Newly established arteriovenous fistula group

Description:

Chronic kidney disease stage 5 (CKD5) non-dialysis patients planning to undergo internal arteriovenous fistula surgery.

Treatment:

Device: A device for detecting arteriovenous fistula vascular function

reconstructed arteriovenous fistula group

Description:

Patients with maintenance hemodialysis who need to reconstruct the internal arteriovenous fistula on account of dissatisfaction with blood flow.

Treatment:

Device: A device for detecting arteriovenous fistula vascular function