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

NCT05531825 | Unknown

• 1 other identifier: SHSY-IEC-5.0/22K54/P01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

  Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

  2 month

Study Arms (4)

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

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

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

Long-term maintenance hemodialysis group

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

Device: A device for detecting arteriovenous fistula vascular function

Interventions

A device for detecting arteriovenous fistula vascular function 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; Newly established arteriovenous fistula group; Normal control group; reconstructed arteriovenous fistula group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age 18-75.
• Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis.
• Sign the informed consent.

You may not qualify if:

• Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness.
• Other circumstances deemed inappropriate by the researcher
• Quit midway

Sponsors & Collaborators

• Ai Peng: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200272, China

RECRUITING

Study Officials

• Ai Peng, MD,PhD

  Shanghai 10th People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Ai Peng, MD,PhD

CONTACT

86-21-66302524; pengai@tongji.edu.cn

Dayong Hu

CONTACT

86-21-66302527; shiyuanhudayong@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Department of Nephrology

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)