Venous RefluxPhase 4RECOVERYNCT00509392

ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

A Phase 4 study testing Seg. RF Ablation & ClosureFAST catheter and Endovenous Laser in people with Venous Reflux, run by Medtronic Endovascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Venous Reflux
What is being tested?: Seg. RF Ablation & ClosureFAST catheter and Endovenous Laser
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Jan 2008
Phase: Phase 4
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

All subjects must provide written informed consent.
Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Who cannot join

Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
Subjects who are participating in another investigational study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health Sciences
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Read the detailed description

Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Conditions: Venous Reflux
Being tested: Seg. RF Ablation & ClosureFAST catheter, Endovenous Laser
Keywords: Varicose veins, venous reflux, GSV disease
Medical subject headings: Varicose Veins

What participants receive

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

Seg. RF Ablation & ClosureFAST catheterDevice
Also called VNUS
Seg. RF Ablation \& ClosureFAST catheter
Endovenous LaserDevice
Also called Commercially approved laser catheter systems.
laser catheter

Study groups in NCT00509392
Study group	Role	What they receive
Seg. RF Ablation & ClosureFAST catheter	Active comparator	Seg. RF Ablation \& ClosureFAST catheter Receives: Device: Seg. RF Ablation & ClosureFAST catheter
Endovenous Laser	Active comparator	Treatment invention of venous disease with an Endovenous Laser. Receives: Device: Endovenous Laser

What is being measured

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

Pain
Pain 0-10 scale (10 most severe)
Measured: 48 Hour
Pain
Pain 0-10 scale (10 most severe)
Measured: 1 Week
Pain
Pain 0-10 scale (10 most severe)
Measured: 2 Weeks
Pain
Pain 0-10 scale (10 most severe)
Measured: 1 Month
Tenderness
Tenderness 0-10 scale (10 most severe)
Measured: 48 Hour
Tenderness
Tenderness 0-10 scale (10 most severe)
Measured: 1 Week
Tenderness
Tenderness 0-10 scale (10 most severe)
Measured: 2 Weeks
Tenderness
Tenderness 0-10 scale (10 most severe)
Measured: 1 Month
Ecchymosis
0-5 scale (5 most severe) 0: None
1. <25%
2. 25-50%
3. 50-75%
4. 75-100%
5. Above or below treated (tx) segment
Measured: 48 Hours post treatment (no baseline)
Ecchymosis
0-5 scale (5 most severe) 0: None
1. <25%
2. 25-50%
3. 50-75%
4. 75-100%
5. Above or below tx segment
Measured: 1 Week post treatment (no baseline)
Ecchymosis
0-5 scale (5 most severe) 0: None
1. <25%
2. 25-50%
3. 50-75%
4. 75-100%
5. Above or below tx segment
Measured: 2 Weeks post treatment (no baseline)
Ecchymosis
0-5 scale (5 most severe) 0: None
1. <25%
2. 25-50%
3. 50-75%
4. 75-100%
5. Above or below tx segment
Measured: 1 Month post treatment (no baseline)
Complications
Sequelae at any follow-up
Measured: 1 month

Secondary outcomes (8)

VCSS
Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Measured: 48 Hours
VCSS
Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Measured: 1 Week
VCSS
Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Measured: 2 Weeks
VCSS
Venous Clinical Severity Score (0-30 total overall score):
0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Measured: 1 Month
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline
Measured: 48 Hours
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline
Measured: 1 Week
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline
Measured: 2 Week
Change in CIVIQ QOL
Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).
Global index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.
Change from Baseline
Measured: 1 Month

Timeline

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

Mar 2007Jan 2008

First posted31 Jul 2007 (estimated)
Study startMar 2007
Primary completionJan 2008
Study completionJan 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Venous RefluxStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00509392
Sponsor's protocol ID: CVL-06-03
Acronym: RECOVERY
Status last verified: Jun 2017
First submitted: 27 Jul 2007
Last updated: 12 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.
PubMed 19395275

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

Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
Active, not recruitingPhase 3
Endovenous Laser Ablation With 1940 nm Versus 1470 nm
Varicose Veins of Lower Limb, Great Saphenous Vein (GSV) With Venous Reflux Disease
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
Varicose Veins of Lower Limb, Hemorrhoids
Active, not recruiting
Venclose digiRF System Post Market Study
Venous Reflux, Chronic Venous Insufficiency
Recruiting
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Varicose Veins, Chronic Venous Insufficiency

All Venous Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)
ClinicalTrials.gov ID: NCT00509392
Acronym / sponsor ID: RECOVERY / CVL-06-03
Conditions: Venous Reflux
Keywords: Varicose veins, venous reflux, GSV disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Medtronic EndovascularIndustry (pharma, biotech, devices)
Collaborators: VNUS Medical Technologies, A Covidien Company
Study start: Mar 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 31 Jul 2007 (estimated)
Results: Posted 12 Jul 2017

Clinical summary

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

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Detailed description

Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Seg. RF Ablation & ClosureFAST catheter	Active comparator	Device: Seg. RF Ablation & ClosureFAST catheterSeg. RF Ablation \& ClosureFAST catheter
Endovenous Laser	Active comparator	Device: Endovenous LaserTreatment invention of venous disease with an Endovenous Laser.

Who may qualify

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

Key inclusion criteria (2 listed)

All subjects must provide written informed consent.
Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Key exclusion criteria (2 listed)

Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
Subjects who are participating in another investigational 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
Seg. RF Ablation & ClosureFAST catheterAlso: VNUSSeg. RF Ablation \& ClosureFAST catheter	Device	Seg. RF Ablation & ClosureFAST catheter
Endovenous LaserAlso: Commercially approved laser catheter systems.laser catheter	Device	Endovenous Laser

Primary outcome

Pain
Time frame: 48 Hour
Pain 0-10 scale (10 most severe)
Pain
Time frame: 1 Week
Pain 0-10 scale (10 most severe)
Pain
Time frame: 2 Weeks
Pain 0-10 scale (10 most severe)
Pain
Time frame: 1 Month
Pain 0-10 scale (10 most severe)
Tenderness
Time frame: 48 Hour
Tenderness 0-10 scale (10 most severe)
Tenderness
Time frame: 1 Week
Tenderness 0-10 scale (10 most severe)
Tenderness
Time frame: 2 Weeks
Tenderness 0-10 scale (10 most severe)
Tenderness
Time frame: 1 Month
Tenderness 0-10 scale (10 most severe)
Ecchymosis
Time frame: 48 Hours post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. <25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below treated (tx) segment
Ecchymosis
Time frame: 1 Week post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. <25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
Ecchymosis
Time frame: 2 Weeks post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. <25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
Ecchymosis
Time frame: 1 Month post treatment (no baseline)
0-5 scale (5 most severe) 0: None 1. <25% 2. 25-50% 3. 50-75% 4. 75-100% 5. Above or below tx segment
Complications
Time frame: 1 month
Sequelae at any follow-up

8 secondary outcomes

VCSS
Time frame: 48 Hours
VCSS
Time frame: 1 Week
VCSS
Time frame: 2 Weeks
VCSS
Time frame: 1 Month
Change in CIVIQ QOL
Time frame: 48 Hours
Change in CIVIQ QOL
Time frame: 1 Week
Change in CIVIQ QOL
Time frame: 2 Week
Change in CIVIQ QOL
Time frame: 1 Month

Results and safety

Results posted to the registry on 12 Jul 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
Radiofrequency (RF) Ablation	32	32
Endovenous Laser (EVL) Ablation	33	33
RF / EVLA	4	4

Primary outcome: Pain

Time frame: 48 Hour. Mean (Standard Deviation). Unit: units on a scale

Measure	Radiofrequency (RF) Ablation n = 34	Endovenous Laser (EVL) Ablation n = 35
Value	0.7 (0.9)	1.9 (1.6)

Radiofrequency (RF) Ablation vs Endovenous Laser (EVL) Ablation: p <0.0001, t-test, 2 sided

Population analysed: Data available at 48 hr follow-up visit

Primary outcome: Pain

Time frame: 1 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Radiofrequency (RF) Ablation n = 34	Endovenous Laser (EVL) Ablation n = 35
Value	0.2 (0.6)	1.8 (1.8)

Radiofrequency (RF) Ablation vs Endovenous Laser (EVL) Ablation: p <0.0001, t-test, 2 sided

Population analysed: Data available at 1-week follow-up visit.

Primary outcome: Pain

Time frame: 2 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Radiofrequency (RF) Ablation n = 34	Endovenous Laser (EVL) Ablation n = 35
Value	0.1 (0.4)	1.2 (1.7)

Radiofrequency (RF) Ablation vs Endovenous Laser (EVL) Ablation: p <0.0001, t-test, 2 sided

Population analysed: Data available at 2-week follow-up visit

Primary outcome: Pain

Time frame: 1 Month. Mean (Standard Deviation). Unit: units on a scale

Measure	Radiofrequency (RF) Ablation n = 34	Endovenous Laser (EVL) Ablation n = 35
Value	0.2 (0.8)	0.4 (1.2)

Radiofrequency (RF) Ablation vs Endovenous Laser (EVL) Ablation: p = 0.2962, t-test, 2 sided

Population analysed: Data available at 1 month follow-up visit

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiofrequency (RF) Ablation	0 of 46 (0%)	2 of 46 (4.3%)	Not reported
Endovenous Laser (EVL) Ablation	1 of 41 (2.4%)	9 of 41 (22%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19395275Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.
Individual participant dataSharing planned: Yes

Related trials for Venous Reflux

Active, not recruiting
Effectiveness of a Needle-free Connector With Anti-reflux Technology in Reducing Complications From Long Peripheral Venous Catheters in Hospitalised Adult Patients: Randomised Clinical Trial
Vascular Access Devices, Catheters
Active, not recruitingPhase 3
Endovenous Laser Ablation With 1940 nm Versus 1470 nm
Varicose Veins of Lower Limb, Great Saphenous Vein (GSV) With Venous Reflux Disease
RecruitingObservational study
HEMOVAR Study on Hemorrhoids and Varicose Veins
Varicose Veins of Lower Limb, Hemorrhoids
Active, not recruiting
Venclose digiRF System Post Market Study
Venous Reflux, Chronic Venous Insufficiency
Recruiting
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Varicose Veins, Chronic Venous Insufficiency

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.

Lian Cunningham, MD study director

VNUS Medical Technologies, A Covidien Company

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Seg. RF Ablation & ClosureFAST catheter and Endovenous Laser in people with Venous Reflux, run by Medtronic Endovascular at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 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?

Pain (time frame: 48 Hour). The study lists 13 primary outcomes in all. 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 NCT00509392, which also lists 1 linked publication.

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 12 Jul 2017.