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

Hemodialysis Access Clinical Trial

Official title: Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Access

• NCT number: NCT00479180
• Study type: Interventional
• Source: Pervasis Therapeutics, Inc
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2006
• Completion date: June 2010