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

NCT00479180 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2011-10-27

No results posted yet for this study

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.

Conditions

  • Hemodialysis Access

Interventions

BIOLOGICAL

Vascugel

One time implant on the day of surgery

BIOLOGICAL

Placebo Comparator

One time implant on the day of surgery

Sponsors & Collaborators

  • Pervasis Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479180 on ClinicalTrials.gov