RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

NCT ID: NCT01079598

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-01-31

Brief 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).

Detailed 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.

Conditions

Venous Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

RF ablation with ClosureRFS Stylet

Group Type: OTHER

RF Ablation (ClosureRFS Stylet)

Intervention Type: DEVICE

Bipolar energy radiofrequency ablation with RFS stylet

Interventions

RF Ablation (ClosureRFS Stylet)

Bipolar energy radiofrequency ablation with RFS stylet

Intervention Type: DEVICE

Other Intervention Names

RFS; RFS Stylet; ClosureRFS Stylet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Endovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Hasenbank, PhD

Role: STUDY_DIRECTOR

Medtronic

Locations

Varicosity Vein Center

Birmingham, Alabama, United States

Vein Care Pavilion of the South

Evans, Georgia, United States

Allegiance Vascular Health

Jackson, Michigan, United States

Countries

United States

Other Identifiers

RFS-09-01

Identifier Type: -

Identifier Source: org_study_id