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

September 4, 2022 updated by: Ai Peng
Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200272
        • Recruiting
        • Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with end-stage renal disease undergoing or planning regular hemodialysis with autologous arteriovenous fistulas

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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
Newly established arteriovenous fistula group
Chronic kidney disease stage 5 (CKD5) non-dialysis patients planning to undergo internal arteriovenous fistula surgery.
Device: 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
reconstructed arteriovenous fistula group
Patients with maintenance hemodialysis who need to reconstruct the internal arteriovenous fistula on account of dissatisfaction with blood flow.
Device: 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
Long-term maintenance hemodialysis group
Patients undergoing hemodialysis with long-term fixed internal arteriovenous fistula.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ai Peng

Investigators

  • Study Director: Ai Peng, MD,PhD, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 4, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 4, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSY-IEC-5.0/22K54/P01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arteriovenous Fistula Flow Monitoring

Clinical Trials on A device for detecting arteriovenous fistula vascular function

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe