Venous InsufficiencyTRIPLENCT01079598

RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

A study testing RF Ablation (ClosureRFS Stylet) in people with Venous Insufficiency, run by Medtronic Endovascular at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Venous Insufficiency
What is being tested?: RF Ablation (ClosureRFS Stylet)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: Mar 2010to Jan 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Varicosity Vein Center
Birmingham, Alabama, 35213
Vein Care Pavilion of the South
Evans, Georgia, 30809
Allegiance Vascular Health
Jackson, Michigan, 49201

Other trials in United States

About this study

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

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).

Read the 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
Being tested: RF Ablation (ClosureRFS Stylet)
Keywords: IPV, RadioFrequency, QOL
Medical subject headings: Venous Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RF Ablation (ClosureRFS Stylet)Device
Also called RFS, RFS Stylet, ClosureRFS Stylet
Bipolar energy radiofrequency ablation with RFS stylet

Study groups in NCT01079598
Study group	Role	What they receive
Treatment	Other	RF ablation with ClosureRFS Stylet Receives: Device: RF Ablation (ClosureRFS Stylet)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (3)

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.
Measured: 6 months
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
CEAP Classification at Month 6 will be reported.
Measured: 6 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jan 2011

First posted3 Mar 2010 (estimated)
Study startMar 2010
Primary completionJan 2011
Study completionJan 2011

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01079598
Sponsor's protocol ID: RFS-09-01
Acronym: TRIPLE
Status last verified: Mar 2017
First submitted: 24 Feb 2010
Last updated: 5 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Out of a planned 225 patient subject size, a total of 8 subjects were enrolled with 10 limbs treated. As a result of stagnant enrollment in the study, a decision was made to terminate the study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease

All Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet
ClinicalTrials.gov ID: NCT01079598
Acronym / sponsor ID: TRIPLE / RFS-09-01
Conditions: Venous Insufficiency
Keywords: IPV, RadioFrequency, QOL
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 8 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 3 Mar 2010 (estimated)
Results: Posted 5 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Device: RF Ablation (ClosureRFS Stylet)RF ablation with ClosureRFS Stylet

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RF Ablation (ClosureRFS Stylet)Also: RFS, RFS Stylet, ClosureRFS StyletBipolar energy radiofrequency ablation with RFS stylet	Device	Treatment

Primary outcome

Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
Time frame: 6 months
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.

3 secondary outcomes

Cessation of Flow Through the Perforator Vein
Time frame: 6 months
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
Time frame: 6 months
Cessation of Flow Reflux Through the Perforator Vein
Time frame: 6 months

Results and safety

Results posted to the registry on 5 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	8	8

Primary outcome: Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.

Time frame: 6 months

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	1 of 8 (12.5%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Out of a planned 225 patient subject size, a total of 8 subjects were enrolled with 10 limbs treated. As a result of stagnant enrollment in the study, a decision was made to terminate the study.

Related trials for Venous Insufficiency

Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Hasenbank, PhD study director

Medtronic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RF Ablation (ClosureRFS Stylet) in people with Venous Insufficiency, run by Medtronic Endovascular at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life and Clinical Assessments Compared to Pretreatment Baseline. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01079598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.