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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509392

Acronym

RECOVERY

Enrollment

Registered

2007-07-31

Start date

2007-03-31

Completion date

2008-01-31

Last updated

2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Reflux

Keywords

Varicose veins, venous reflux, GSV disease

Brief 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.

Detailed description

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

Interventions

DEVICESeg. RF Ablation & ClosureFAST catheter

Seg. RF Ablation & ClosureFAST catheter

DEVICEEndovenous Laser

laser catheter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Pain	48 Hour	Pain 0-10 scale (10 most severe)
Tenderness	48 Hour	Tenderness 0-10 scale (10 most severe)
Ecchymosis	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
Complications	1 month	Sequelae at any follow-up

Secondary

Measure	Time frame	Description
VCSS	48 Hours	Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease
Change in CIVIQ QOL	48 Hours	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

Countries

United States

Participant flow

Recruitment details

Recruitment from March - December 2007. Medical offices/clinics and university hospital.

Participants by arm

Arm	Count
Radiofrequency (RF) Ablation Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	34
Radiofrequency (RF) Ablation Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)	46
Endovenous Laser (EVL) Ablation Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)	35
Endovenous Laser (EVL) Ablation Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)	41
Total	156

Baseline characteristics

Characteristic	Total	Endovenous Laser (EVL) Ablation	Radiofrequency (RF) Ablation
Age, Categorical <=18 years	0 limbs	0 limbs	0 limbs
Age, Categorical >=65 years	17 limbs	11 limbs	6 limbs
Age, Categorical Between 18 and 65 years	70 limbs	30 limbs	40 limbs
Age, Continuous	52.37 Years STANDARD_DEVIATION 15.3	52.4 Years STANDARD_DEVIATION 15.3	51.6 Years STANDARD_DEVIATION 12.8
CEAP CEAP Class 2	79 limbs	36 limbs	43 limbs
CEAP Not CEAP Class 2	8 limbs	5 limbs	3 limbs
CIVIQ	40.3 Score on a questionnaire STANDARD_DEVIATION 15.9	40 Score on a questionnaire STANDARD_DEVIATION 14.5	40.6 Score on a questionnaire STANDARD_DEVIATION 17.2
Region of Enrollment Germany	39 limbs	18 limbs	21 limbs
Region of Enrollment United States	48 limbs	23 limbs	25 limbs
Sex: Female, Male Female	69 limbs	31 limbs	38 limbs
Sex: Female, Male Male	18 limbs	10 limbs	8 limbs
VCSS	4.8 Scores on a scale STANDARD_DEVIATION 3	4.9 Scores on a scale STANDARD_DEVIATION 2.8	4.7 Scores on a scale STANDARD_DEVIATION 3.1

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 46	9 / 41
serious Total, serious adverse events	0 / 46	1 / 41

Outcome results

Primary

Complications

Sequelae at any follow-up

Time frame: 1 month

Population: Data up to one month follow up visit

Arm	Measure	Group	Value (COUNT_OF_UNITS)
Radiofrequency (RF) Ablation	Complications	Hyperpigmentation	1 limbs
Radiofrequency (RF) Ablation	Complications	Phlebitis	0 limbs
Radiofrequency (RF) Ablation	Complications	Paresthesia	2 limbs
Radiofrequency (RF) Ablation	Complications	Erythema	0 limbs
Radiofrequency (RF) Ablation	Complications	Infection	0 limbs
Radiofrequency (RF) Ablation	Complications	Thrombus Extention (TE)/Deep Vein Thrombosis (DVT)	0 limbs
Endovenous Laser (EVL) Ablation	Complications	Infection	0 limbs
Endovenous Laser (EVL) Ablation	Complications	Hyperpigmentation	0 limbs
Endovenous Laser (EVL) Ablation	Complications	Erythema	6 limbs
Endovenous Laser (EVL) Ablation	Complications	Phlebitis	8 limbs
Endovenous Laser (EVL) Ablation	Complications	Thrombus Extention (TE)/Deep Vein Thrombosis (DVT)	3 limbs
Endovenous Laser (EVL) Ablation	Complications	Paresthesia	3 limbs

Primary

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

Time frame: 1 Month post treatment (no baseline)

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

Arm	Measure	Group	Value (NUMBER)
Radiofrequency (RF) Ablation	Ecchymosis	0	45 limbs
Radiofrequency (RF) Ablation	Ecchymosis	1	1 limbs
Radiofrequency (RF) Ablation	Ecchymosis	2	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	3	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	4	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	4	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	0	31 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	3	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	1	9 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	2	0 limbs

p-value: 0.005Fisher Exact

Primary

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

Time frame: 2 Weeks post treatment (no baseline)

Population: Intent to treat/ SP: Data available at 2-week follow-up visit

Arm	Measure	Group	Value (NUMBER)
Radiofrequency (RF) Ablation	Ecchymosis	0	35 limbs
Radiofrequency (RF) Ablation	Ecchymosis	1	7 limbs
Radiofrequency (RF) Ablation	Ecchymosis	2	1 limbs
Radiofrequency (RF) Ablation	Ecchymosis	3	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	4	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	4	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	0	13 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	3	2 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	1	18 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	2	6 limbs

p-value: <0.0001Fisher Exact

Primary

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

Time frame: 1 Week post treatment (no baseline)

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

Arm	Measure	Group	Value (NUMBER)
Radiofrequency (RF) Ablation	Ecchymosis	3	1 limbs
Radiofrequency (RF) Ablation	Ecchymosis	4	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	5	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	0	26 limbs
Radiofrequency (RF) Ablation	Ecchymosis	1	13 limbs
Radiofrequency (RF) Ablation	Ecchymosis	2	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	2	10 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	3	4 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	1	12 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	4	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	0	9 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	5	0 limbs

p-value: <0.0001Fisher Exact

Primary

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

Time frame: 48 Hours post treatment (no baseline)

Population: Data available at 48hrs follow-up visit

Arm	Measure	Group	Value (NUMBER)
Radiofrequency (RF) Ablation	Ecchymosis	0	30 limbs
Radiofrequency (RF) Ablation	Ecchymosis	1	15 limbs
Radiofrequency (RF) Ablation	Ecchymosis	2	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	3	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	4	0 limbs
Radiofrequency (RF) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	4	1 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	0	8 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	3	5 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	1	13 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	5	0 limbs
Endovenous Laser (EVL) Ablation	Ecchymosis	2	14 limbs

p-value: <0.0001Fisher Exact

Primary

Pain

Pain 0-10 scale (10 most severe)

Time frame: 48 Hour

Population: Data available at 48 hr follow-up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Pain	0.7 units on a scale	Standard Deviation 0.9
Endovenous Laser (EVL) Ablation	Pain	1.9 units on a scale	Standard Deviation 1.6

p-value: <0.0001t-test, 2 sided

Primary

Pain

Pain 0-10 scale (10 most severe)

Time frame: 1 Week

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

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Pain	0.2 units on a scale	Standard Deviation 0.6
Endovenous Laser (EVL) Ablation	Pain	1.8 units on a scale	Standard Deviation 1.8

p-value: <0.0001t-test, 2 sided

Primary

Pain

Pain 0-10 scale (10 most severe)

Time frame: 2 Weeks

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

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Pain	0.1 units on a scale	Standard Deviation 0.4
Endovenous Laser (EVL) Ablation	Pain	1.2 units on a scale	Standard Deviation 1.7

p-value: <0.0001t-test, 2 sided

Primary

Pain

Pain 0-10 scale (10 most severe)

Time frame: 1 Month

Population: Data available at 1 month follow-up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Pain	0.2 units on a scale	Standard Deviation 0.8
Endovenous Laser (EVL) Ablation	Pain	0.4 units on a scale	Standard Deviation 1.2

p-value: 0.2962t-test, 2 sided

Primary

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 1 Month

Population: Data available at 1 month follow-up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Tenderness	0.3 units on a scale	Standard Deviation 1
Endovenous Laser (EVL) Ablation	Tenderness	0.5 units on a scale	Standard Deviation 1.2

p-value: 0.5761t-test, 2 sided

Primary

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 2 Weeks

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

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Tenderness	0.3 units on a scale	Standard Deviation 0.7
Endovenous Laser (EVL) Ablation	Tenderness	1.2 units on a scale	Standard Deviation 1.5

p-value: 0.0005t-test, 2 sided

Primary

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 1 Week

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

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Tenderness	0.5 units on a scale	Standard Deviation 1.2
Endovenous Laser (EVL) Ablation	Tenderness	1.6 units on a scale	Standard Deviation 1.8

p-value: 0.0036t-test, 2 sided

Primary

Tenderness

Tenderness 0-10 scale (10 most severe)

Time frame: 48 Hour

Population: Data available at 48hr visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Tenderness	0.9 units on a scale	Standard Deviation 1.3
Endovenous Laser (EVL) Ablation	Tenderness	2.0 units on a scale	Standard Deviation 2.3

p-value: 0.0048t-test, 2 sided

Secondary

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

Time frame: 1 Month

Population: Data at 1 month follow-up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Change in CIVIQ QOL	-17.8 units on a scale	Standard Deviation 15.4
Endovenous Laser (EVL) Ablation	Change in CIVIQ QOL	-17.5 units on a scale	Standard Deviation 15.2

p-value: 0.9463t-test, 2 sided

Secondary

Change in CIVIQ QOL

Time frame: 48 Hours

Population: Data at 48 hrs follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Change in CIVIQ QOL	-13.5 units on a scale	Standard Deviation 14.6
Endovenous Laser (EVL) Ablation	Change in CIVIQ QOL	-7.1 units on a scale	Standard Deviation 19

p-value: 0.0854t-test, 2 sided

Secondary

Change in CIVIQ QOL

Time frame: 1 Week

Population: Data at one week follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Change in CIVIQ QOL	-19.1 units on a scale	Standard Deviation 13.9
Endovenous Laser (EVL) Ablation	Change in CIVIQ QOL	-9.4 units on a scale	Standard Deviation 13.3

p-value: 0.0044t-test, 2 sided

Secondary

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

Time frame: 2 Week

Population: Data at 2-week follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	Change in CIVIQ QOL	-19.9 units on a scale	Standard Deviation 14.7
Endovenous Laser (EVL) Ablation	Change in CIVIQ QOL	-12.4 units on a scale	Standard Deviation 17.6

p-value: 0.0457t-test, 2 sided

Secondary

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 48 Hours

Population: Data at 48 hours for follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	VCSS	4.7 units on a scale	Standard Deviation 1.6
Endovenous Laser (EVL) Ablation	VCSS	6.2 units on a scale	Standard Deviation 2.5

p-value: 0.0009t-test, 2 sided

Secondary

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 1 Week

Population: Data at 1-week follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	VCSS	4.2 units on a scale	Standard Deviation 1.5
Endovenous Laser (EVL) Ablation	VCSS	5.9 units on a scale	Standard Deviation 2.3

p-value: 0.0002t-test, 2 sided

Secondary

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 2 Weeks

Population: Data at 2 week follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	VCSS	4.0 units on a scale	Standard Deviation 1.8
Endovenous Laser (EVL) Ablation	VCSS	5.3 units on a scale	Standard Deviation 1.9

p-value: 0.0035t-test, 2 sided

Secondary

VCSS

Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

Time frame: 1 Month

Population: Data at 1- month follow up visit

Arm	Measure	Value (MEAN)	Dispersion
Radiofrequency (RF) Ablation	VCSS	2.7 units on a scale	Standard Deviation 2.2
Endovenous Laser (EVL) Ablation	VCSS	3.2 units on a scale	Standard Deviation 1.8

p-value: 0.2825t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Complications

Ecchymosis

Ecchymosis

Ecchymosis

Ecchymosis

Pain

Pain

Pain

Pain

Tenderness

Tenderness

Tenderness

Tenderness

Change in CIVIQ QOL

Change in CIVIQ QOL

Change in CIVIQ QOL

Change in CIVIQ QOL

VCSS

VCSS

VCSS

VCSS