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Clinical Trials/NCT02119845
NCT02119845
Completed
Not Applicable

A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001

C. R. Bard1 site in 1 country16 target enrollmentAugust 1, 2012
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ConditionsChronic Kidney Disease (CKD)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease (CKD)
Sponsor
C. R. Bard
Enrollment
16
Locations
1
Primary Endpoint
Adverse Events
Status
Completed
Last Updated
5 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.

Registry
clinicaltrials.gov
Start Date
August 1, 2012
End Date
April 1, 2013
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
C. R. Bard
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
  • •Adult (age \>18 years old).
  • •Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
  • •Written informed consent obtained

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 6 months

The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.

Secondary Outcomes

  • Access Functionality(6 Months)

Study Sites (1)

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