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

NCT ID: NCT05531825

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal control group

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

A device for detecting arteriovenous fistula vascular function

Intervention Type DEVICE

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

Newly established arteriovenous fistula group

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

A device for detecting arteriovenous fistula vascular function

Intervention Type DEVICE

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

reconstructed arteriovenous fistula group

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

A device for detecting arteriovenous fistula vascular function

Intervention Type DEVICE

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

Long-term maintenance hemodialysis group

Patients undergoing hemodialysis with long-term fixed internal arteriovenous fistula.

A device for detecting arteriovenous fistula vascular function

Intervention Type DEVICE

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

Interventions

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A 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ai Peng

OTHER

Sponsor Role lead

Responsible Party

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Ai Peng

Director of the Department of Nephrology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ai Peng, MD,PhD

Role: STUDY_DIRECTOR

Shanghai 10th People's Hospital

Locations

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Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ai Peng, MD,PhD

Role: CONTACT

86-21-66302524

Dayong Hu

Role: CONTACT

86-21-66302527

Facility Contacts

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Ai Peng, MD,PhD

Role: primary

Other Identifiers

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SHSY-IEC-5.0/22K54/P01

Identifier Type: -

Identifier Source: org_study_id

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