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

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

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

NCT02119845•C. R. Bard

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Italian Hospital

Asunción, Paraguay

Key Dates

Start Date

August 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

November 26, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Kidney Disease (CKD)

Interventions

Endovascular AVF (EndoAVF)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Domperidone and the Risk of Serious Adverse Events

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Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial