NCT01471041

Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Vital Access Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.

Conditions

• End Stage Renal Disease
• AV Fistula
• Kidney Failure

Interventions

Type	Name	Description
DEVICE	Venous Window Needle Guide	Subcutaneous, extravascular needle guide made of medical-grade titanium

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2011-11-11
• Last updated: 2016-06-03
• Results posted: 2016-06-03

Locations

2 sites across 1 country: United States