Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Recruiting N/A Interventional Study
End Stage Renal Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
300 (estimated)
Sponsor
Laminate Medical Technologies · Industry
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About This Trial

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study. 2. Male and non-pregnant female participants. 3.…
Contacts

Galit Itzhaki

+972-3-6344246

galit@laminatemedical.com

CONTACT