Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249373
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-29
Brief Title:
The Effect of LIPUS on the Maturation of Newly Constructed Autogenous AVF
Sponsor:
Suzhou Municipal Hospital
Organization:
Suzhou Municipal Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial on the Effect of Low-intensity Pulsed Ultrasound on the Maturation of Newly Constructed Autogenous Arteriovenous Fistulas in Uremic Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None