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NCT00565604 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins

A NA study, sponsored by Vascular Solutions.

Completed
Registry status
NA
Development phase
43
Enrollment target

NCT00565604: Completed NA study, sponsored by Vascular Solutions.

NCT00565604 is a NA study that has completed, run by Vascular Solutions. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00565604, a NA study, has completed, sponsored by Vascular Solutions.

COMPLETED
Registry status
NA
Development phase
43 participants
Enrollment target

Study Summary

This trial is designed as a prospective, non randomized, single center clinical trial to determine the safety and efficacy of laser ablation of incompetent perforator veins. Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex ultrasound will verify the presence or absence of incompetent perforator veins (IPV). In addition, the number, diameter and location of the IPVs will be determined. Limbs with IPVs which measure greater than or equal to 3mm in diameter and are located superior to the foot and distal ankle will be considered for entry into the study.

Primary Outcome

The primary objective is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated incompetent perforated vein \[IPV\])) of endovenous laser ablation. The number of treated IPVs that are closed at 6 weeks and remain closed at 6 months.

Interventions

  • DEVICE Short Catheter Delivery

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2007-10
Est. Completion 2009-06
Phase NA
Vascular Solutions

7 total trials

What the finished NCT00565604 record still lists

NCT00565604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Short Catheter Delivery is the first listed.

NCT00565604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00565604 about?

NCT00565604 is a clinical study titled "Safety and Efficacy of Endovenous Laser Ablation for the Resolution of Incompetent Perforator Veins". This trial is designed as a prospective, non randomized, single center clinical trial to determine the safety and efficacy of laser ablation of incompetent perforator veins. Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A duplex ultrasound will verify the prese...

What is the current status of trial NCT00565604?

This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2007-10. Estimated completion is 2009-06.

What interventions are being tested in trial NCT00565604?

The interventions under investigation include: Short Catheter Delivery (DEVICE).

Who is sponsoring clinical trial NCT00565604?

This trial is sponsored by Vascular Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00565604's enrollment target sits among peer trials

43 1435th of 2000 higher than 565 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00565604, the US trial registry maintained by the National Library of Medicine. NCT00565604 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.