Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479180
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2007-05-24
Brief Title:
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Sponsor:
Pervasis Therapeutics Inc
Organization:
Pervasis Therapeutics Inc
Study Overview
Official Title:
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Status:
COMPLETED
Status Verified Date:
2011-10
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:
Vascugel is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access
Detailed Description:
Randomized double-blind parallel group Phase III clinical trial of Vascugel treatment vs Gelfoam in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access
All patients will undergo preoperative duplex ultrasound imaging andor angiography whatever is the standard of care at the research site of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity
Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula
During the follow-up period each patient will undergo a physical examination and imaging of the vascular access at specified intervals
All patients will undergo preoperative duplex ultrasound imaging andor angiography whatever is the standard of care at the research site of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity
Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula
During the follow-up period each patient will undergo a physical examination and imaging of the vascular access at specified intervals
Study Oversight
Has Oversight DMC:
None
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?:
None