Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT01669850
Status:
TERMINATED
Last Update Posted:
2015-09-07
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clipped Versus Handsewn Arteriovenous Fistula Anastomosis
Sponsor:
Gundersen Lutheran Medical Foundation
Organization:
Study Overview
Official Title:
The Safety and Effectiveness of Clipped Technique vs. Hand-Sewn Technique for Anastomosis in Arteriovenous Fistulas
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
minimal accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.
Detailed Description:
End stage renal disease requiring hemodialysis has become more prevalent in recent years. Achieving vascular access is an important step in receiving hemodialysis. Recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. Multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. The use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. Further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. The purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: