RFS - Radiofrequency Perforator Vein Treatment Study

Venous Insufficiency Clinical Trial

— TRIPLE  

Official title:

A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079598
• Other study ID #: RFS-09-01
• Status: Terminated
• Phase: N/A
• First received: February 24, 2010
• Last updated: April 18, 2012
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: VNUS Medical Technologies, A Covidien Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).

Description:

The purpose of this study is to demonstrate that patients who have competent great saphenous vein (GSV) and short saphenous vein (SSV) or have undergone prior successful endovenous treatment of an incompetent GSV and/or SSV but continue to demonstrate clinical symptoms of peripheral venous insufficiency resulting from incompetent perforator veins (IPVs) will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of IPVs veins.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female, ages 18 to 80 years, from all racial and ethnic origin

• Have the ability to understand the requirements of the study, provide written informed consent to participate, and agree to abide by the study requirements

• Available for all the follow-up visits and in a physical condition allowing ambulation after the procedure

• Incompetent GSV and/or SSV in the target limb has been treated at least 3 months before study enrollment or competent GSV and SSV at time of treatment

• CEAP 4 - 6 classification

• DUS reflux of =0.35 sec or more of the target IPV and/or an intra-fascia diameter of =0.3 mm

Exclusion Criteria:

• Acute (at Screening) superficial venous thrombosis of either limb

• Acute (within the prior 3 months) deep venous thrombosis or phlebitis in either limb

• Complete or near complete deep venous obstruction documented by ultrasound

• Previously participated in any study involving ClosureRFS

• Actively participated in any other investigational study within 30 days of enrollment into this study

• Pregnant at the time of treatment. Status verified by pregnancy test via blood or urine for women = 55 years old.

• Having a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all required study follow-up

• Have any condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the trial results

• Have a history of excessive alcohol consumption or any use of illegal drugs rendering the patient unreliable, or at risk during this trial

• Have undergone major surgery which may result in abnormalities of the target body area, reasonably suspected to compromise the study outcomes

• Have undergone an invasive procedure of the target body area (e.g., needle biopsy or surgical procedure) within 30 days of enrollment into this study

• Known incompatibility, such as an allergic reaction to anesthetics to be used in the incompetent perforator vein treatment

• Patients requiring hyperbaric therapy involving the treated limb during the 6 month post treatment follow-up period

• Great toe pressure measurement of = 70 mmHg

• CEAP 6 classified patients receiving high dose steroid medication or the following medications that interfere with normal mechanisms of wound healing, e.g. glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), anti-neoplastic and immunosuppressive drugs, and others like, colchicine and penicillamine.

• Expressing a body mass index (BMI) of = 35.

Study Design

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

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• RF Ablation (ClosureRFS Stylet)
Bipolar energy radiofrequency ablation with RFS stylet

Locations

Country	Name	City	State
United States	Varicosity Vein Center	Birmingham	Alabama
United States	Vein Care Pavilion of the South	Evans	Georgia
United States	Allegiance Vascular Health	Jackson	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VNUS Medical Technologies, A Covidien Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life and clinical assessments compared to pretreatment baseline.		6 months	No
Secondary	Cessation of Flow through the Perforator vein	Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.	6 months	No
Secondary	CEAP classification (Clinical severity, Etiology or cause, Anatomy, Pathophysiology)		6 months	No
Secondary	Cessation of Flow Reflux through the Perforator vein	Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.	6 months	No