Trial Outcomes & Findings for RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study (NCT NCT01079598)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

6 months

Results posted on

2017-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=8 Participants RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.

CEAP Classification at Month 6 will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=8 participants at risk RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
Vascular disorders Thrombus Extension	12.5% 1/8 • Number of events 1 • 6 months Enrollment through study completion

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Brucato, Principal Clinical Research Specialist

Medtronic

Phone: 508-261-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60