NCT00479180

Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Pervasis Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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 I/II 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 and/or 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.

Conditions

• Hemodialysis Access

Interventions

Type	Name	Description
BIOLOGICAL	Vascugel	One time implant on the day of surgery
BIOLOGICAL	Placebo Comparator	One time implant on the day of surgery

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-05-28
• Last updated: 2011-10-27

Locations

1 site across 1 country: United States