Back to resultsA Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
Primary Purpose
Chronic Kidney Disease (CKD)
Status
Completed
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
Endovascular AVF (EndoAVF)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease (CKD) focused on measuring Chronic kidney disease, Arteriovenous fistula (AVF), Hemodialysis, Vascular access, Endovascular AVF (EndoAVF)
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
Sites / Locations
- Italian Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endovascular AVF (EndoAVF)
Arm Description
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
Outcomes
Primary Outcome Measures
Adverse Events
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
Secondary Outcome Measures
Access Functionality
The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02119845
Brief Title
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
Official Title
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVA Medical Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD)
Keywords
Chronic kidney disease, Arteriovenous fistula (AVF), Hemodialysis, Vascular access, Endovascular AVF (EndoAVF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endovascular AVF (EndoAVF)
Arm Type
Experimental
Arm Description
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
Intervention Type
Device
Intervention Name(s)
Endovascular AVF (EndoAVF)
Other Intervention Name(s)
FLEX
Intervention Description
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
Primary Outcome Measure Information:
Title
Adverse Events
Description
The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Access Functionality
Description
The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD
Organizational Affiliation
Italian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Italian Hospital
City
Asuncion
ZIP/Postal Code
1001-1925
Country
Paraguay
12. IPD Sharing Statement
Learn more about this trial
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
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