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| Name | Class |
|---|---|
| VNUS Medical Technologies, A Covidien Company | INDUSTRY |
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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.
Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seg. RF Ablation & ClosureFAST catheter | Active Comparator | Seg. RF Ablation & ClosureFAST catheter |
|
| Endovenous Laser | Active Comparator | Treatment invention of venous disease with an Endovenous Laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seg. RF Ablation & ClosureFAST catheter | Device | Seg. RF Ablation & ClosureFAST catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Pain 0-10 scale (10 most severe) | 48 Hour |
| Pain | Pain 0-10 scale (10 most severe) | 1 Week |
| Pain | Pain 0-10 scale (10 most severe) | 2 Weeks |
| Pain | Pain 0-10 scale (10 most severe) | 1 Month |
| Tenderness | Tenderness 0-10 scale (10 most severe) | 48 Hour |
| Tenderness | Tenderness 0-10 scale (10 most severe) | 1 Week |
| Tenderness | Tenderness 0-10 scale (10 most severe) | 2 Weeks |
| Tenderness | Tenderness 0-10 scale (10 most severe) | 1 Month |
| Ecchymosis | 0-5 scale (5 most severe) 0: None
| 48 Hours post treatment (no baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 48 Hours |
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lian Cunningham, MD | VNUS Medical Technologies, A Covidien Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19395275 | Result | 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. |
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Recruitment from March - December 2007. Medical offices/clinics and university hospital.
| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency (RF) Ablation | Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA) |
| FG001 | Endovenous Laser (EVL) Ablation | Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA) |
| FG002 | RF / EVLA | Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
69 subjects were enrolled and 87 limbs were treated. There were 4 enrolled subjects that had bilateral treatment where one limb was treated with RF and the other limb was treated with EVL. To account for this, 2 subjects were added to the total number of baseline RF participant group and 2 were added to the baseline EVL participant group.
| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency (RF) Ablation | Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA) |
| BG001 | Endovenous Laser (EVL) Ablation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain | Pain 0-10 scale (10 most severe) | Data available at 48 hr follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 48 Hour | limbs | limbs |
|
1 Month
Number of subjects at risk = Number of subjects with adverse event information
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency (RF) Ablation | Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombus extension (TE) into Common Femoral Vein (CFV) | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eppie Chang, MS; Director Clinical Research | VNUS Medical Technologies / Covidien (sponsor) | 408-360-7200 | eppie.chang@covidien.com |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Endovenous Laser | Device | laser catheter |
|
|
| Ecchymosis | 0-5 scale (5 most severe) 0: None
| 1 Week post treatment (no baseline) |
| Ecchymosis | 0-5 scale (5 most severe) 0: None
| 2 Weeks post treatment (no baseline) |
| Ecchymosis | 0-5 scale (5 most severe) 0: None
| 1 Month post treatment (no baseline) |
| Complications | Sequelae at any follow-up | 1 month |
| 1 Week |
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 2 Weeks |
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | 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 | 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 | 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 | 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 | 1 Month |
Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)
| BG002 | Total | Total of all reporting groups |
| limbs |
|
| limbs |
| limbs |
|
| Age, Continuous | Mean | Standard Deviation | Years | Participants |
|
| Sex: Female, Male | Count of Units | limbs | limbs |
|
| Region of Enrollment | Number | limbs | limbs |
|
| VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | Mean | Standard Deviation | Scores on a scale | limbs |
|
| CEAP | Clinical/Etiology/Anatomy/Pathophysiology Score CEAP Class 2: Clinical classification for individuals with varicose veins | Number | limbs | limbs |
|
| CIVIQ | 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. | Mean | Standard Deviation | Score on a questionnaire | limbs |
|
| Units | Counts |
|---|
| Participants |
|
| limbs |
|
|
|
| Primary | Pain | Pain 0-10 scale (10 most severe) | Data available at 1-week follow-up visit. | Posted | Mean | Standard Deviation | units on a scale | 1 Week | limbs | limbs |
|
|
|
|
| Primary | Pain | Pain 0-10 scale (10 most severe) | Data available at 2-week follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | limbs | limbs |
|
|
|
|
| Primary | Pain | Pain 0-10 scale (10 most severe) | Data available at 1 month follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Month | limbs | limbs |
|
|
|
|
| Primary | Tenderness | Tenderness 0-10 scale (10 most severe) | Data available at 48hr visit | Posted | Mean | Standard Deviation | units on a scale | 48 Hour | limbs | limbs |
|
|
|
|
| Primary | Tenderness | Tenderness 0-10 scale (10 most severe) | Data available at 1-week follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Week | limbs | limbs |
|
|
|
|
| Primary | Tenderness | Tenderness 0-10 scale (10 most severe) | Data available at 2-week follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | limbs | limbs |
|
|
|
|
| Primary | Tenderness | Tenderness 0-10 scale (10 most severe) | Data available at 1 month follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Month | limbs | limbs |
|
|
|
|
| Primary | Ecchymosis | 0-5 scale (5 most severe) 0: None
| Data available at 48hrs follow-up visit | Posted | Number | limbs | 48 Hours post treatment (no baseline) | limbs | limbs |
|
|
|
|
| Primary | Ecchymosis | 0-5 scale (5 most severe) 0: None
| Data available at 1-week follow-up visit | Posted | Number | limbs | 1 Week post treatment (no baseline) | limbs | limbs |
|
|
|
|
| Primary | Ecchymosis | 0-5 scale (5 most severe) 0: None
| Intent to treat/ SP: Data available at 2-week follow-up visit | Posted | Number | limbs | 2 Weeks post treatment (no baseline) | limbs | limbs |
|
|
|
|
| Primary | Ecchymosis | 0-5 scale (5 most severe) 0: None
| Data available at 1- month follow-up visit | Posted | Number | limbs | 1 Month post treatment (no baseline) | limbs | limbs |
|
|
|
|
| Primary | Complications | Sequelae at any follow-up | Data up to one month follow up visit | Posted | Count of Units | limbs | 1 month | limbs | limbs |
|
|
|
| Secondary | VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | Data at 48 hours for follow up visit | Posted | Mean | Standard Deviation | units on a scale | 48 Hours | limbs | limbs |
|
|
|
|
| Secondary | VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | Data at 1-week follow up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Week | limbs | limbs |
|
|
|
|
| Secondary | VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | Data at 2 week follow up visit | Posted | Mean | Standard Deviation | units on a scale | 2 Weeks | limbs | limbs |
|
|
|
|
| Secondary | VCSS | Venous Clinical Severity Score (0-30 total overall score): 0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease | Data at 1- month follow up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Month | limbs | limbs |
|
|
|
|
| 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 | Data at 48 hrs follow up visit | Posted | Mean | Standard Deviation | units on a scale | 48 Hours | limbs | limbs |
|
|
|
|
| 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 | Data at one week follow up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Week | limbs | limbs |
|
|
|
|
| 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 | Data at 2-week follow up visit | Posted | Mean | Standard Deviation | units on a scale | 2 Week | limbs | limbs |
|
|
|
|
| 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 | Data at 1 month follow-up visit | Posted | Mean | Standard Deviation | units on a scale | 1 Month | limbs | limbs |
|
|
|
|
| 0 |
| 46 |
| 2 |
| 46 |
| EG001 | Endovenous Laser (EVL) Ablation | Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA) | 1 | 41 | 9 | 41 |
| Phlebitis | Vascular disorders | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
The data/info related to Study are legal property of VNUS & can be used by PI for publication, communication or scientific presentation only after duly informing VNUS of proposed dissemination, providing to VNUS for review/comment a copy of said proposed publication, communication or scientific presentation & allowing at least 30 days from the time of receipt by VNUS for VNUS to provide comment on said proposed publication, communication or scientific presentation prior to said dissemination.
| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 2 |
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| 3 |
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| 4 |
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| 5 |
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| Paresthesia |
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| Erythema |
|
| Infection |
|
| Thrombus Extention (TE)/Deep Vein Thrombosis (DVT) |
|