RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

NCT01079598 | Terminated Results

• 1 other identifier: RFS-09-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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).

Conditions

Venous Insufficiency

Keywords

IPV; RadioFrequency; QOL

Outcome Measures

Primary Outcomes (1)

• Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.

  QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.

  6 months

Secondary Outcomes (3)

• Cessation of Flow Through the Perforator Vein

  6 months

• CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)

  6 months

• Cessation of Flow Reflux Through the Perforator Vein

  6 months

Study Arms (1)

Treatment

OTHER

RF ablation with ClosureRFS Stylet

Device: RF Ablation (ClosureRFS Stylet)

Interventions

RF Ablation (ClosureRFS Stylet) DEVICE

Bipolar energy radiofrequency ablation with RFS stylet

Also known as: RFS, RFS Stylet, ClosureRFS Stylet

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (3)

Varicosity Vein Center

Birmingham, Alabama, 35213, United States

Location

Vein Care Pavilion of the South

Evans, Georgia, 30809, United States

Location

Allegiance Vascular Health

Jackson, Michigan, 49201, United States

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Stephanie Brucato, Principal Clinical Research Specialist
• Organization: Medtronic

stephanie.m.brucato@medtronic.com

508-261-8000

Study Officials

• Melissa Hasenbank, PhD

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: March 3, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 5, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)