Use of a Lifeline Graft in the A-V Shunt Model
NCT00850252 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2013-07-17
Summary
This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.
Conditions
- ESRD
- Hemodialysis
Interventions
- DEVICE
-
Lifeline
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
Sponsors & Collaborators
-
Cytograft Tissue Engineering
lead INDUSTRY
Principal Investigators
-
Luis M de la Fuente, MD · IADT, Buenos Aires, Argentina
-
Lech Cierpka, MD PhD · Department of General, Vascular and Transplant Surgery, Katowice, Poland
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2012-01-31
- Completion
- 2012-12-31
Countries
- Argentina
- Poland
Study Locations
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