The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF

Summary

This study aims to evaluate the effect of 12 week low-intensity pulse ultrasound (LIPUS) intervention on the maturation of newly constructed autologous arteriovenous fistulas in uremic patients. This study is a prospective, blinded, randomized controlled trial. This trial is divided into two stages. The first stage is a concept validation trial, which is a single center, prospective, blinded, randomized controlled clinical study. Subjects who meet the screening criteria are randomly divided into an intervention group and a control group in a 1:1 ratio. All subjects underwent safety and efficacy evaluations at the 2nd, 4th, 8th, 12th, and 4th week after treatment. After completing a 4-week follow-up of the 20th study subject, an analysis was conducted with the preset goal of achieving a higher maturation rate of arteriovenous fistula in the intervention group compared to the control group at the follow-up point, and the safety of the study was evaluated. The second stage is a key trial, which is a multicenter, prospective, blinded, randomized controlled clinical study. The inclusion criteria, primary and secondary endpoints, and safety endpoints of the study subjects remain unchanged, and the safety and efficacy of the overall population are evaluated.

Conditions

• Uremia; Chronic

Interventions

DEVICE

Low intensity pulse ultrasound （LIPUS） intervention for arteriovenous fistula anastomosis

The LIPUS intervention group for arteriovenous fistula should receive forearm wearable portable low-intensity pulse ultrasound （LIPUS） intervention at the anastomotic site no more than 3 days after suture removal two weeks after the fistula surgery. If the ultrasound examination indicates the presence of stenosis in the outflow tract, the intervention should also be performed at the same time. It belongs to non-invasive extracorporeal intervention, with three times a week （during dialysis） for 20 minutes each time. The sound intensity is 350mW/cm2, the pulse frequency is 1MHz, the pulse repetition frequency is 100Hz, the pulse frequency is 100 times, and the treatment period is 12 weeks.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Dushu Lake Hospital Affiliated to Soochow University

  collaborator OTHER

• Suzhou Municipal Hospital

  lead OTHER

Principal Investigators

• Xiangqing Kong · Suzhou Municipal Hospital

• Huijuan Mao · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-26

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• China

Study Locations