A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119845
• Other study ID #: FLEX-1-001
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: April 21, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: TVA Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Paraguay: Ministry of Public Health and Social Wellbeing
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Endovascular AVF (EndoAVF)
The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.

Locations

Country	Name	City	State
Paraguay	Italian Hospital	Asuncion

Sponsors (1)

Lead Sponsor	Collaborator
TVA Medical Inc.

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.	6 months	Yes
Secondary	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.	6 Months	No