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OpenTrials
Completed

NCT Number: NCT00509392

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

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.

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Key information

Conditions

Venous Reflux Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health Sciences

Portland, Oregon, 97239, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seg. RF Ablation & ClosureFAST catheter

Device

Seg. RF Ablation & ClosureFAST catheter

Other names: VNUS

Endovenous Laser

Device

laser catheter

Other names: Commercially approved laser catheter systems.

Primary outcomes

  1. Pain

    Time frame: 48 Hour

    Pain 0-10 scale (10 most severe)

  2. Pain

    Time frame: 1 Week

    Pain 0-10 scale (10 most severe)

  3. Pain

    Time frame: 2 Weeks

    Pain 0-10 scale (10 most severe)

  4. Pain

    Time frame: 1 Month

    Pain 0-10 scale (10 most severe)

  5. Tenderness

    Time frame: 48 Hour

    Tenderness 0-10 scale (10 most severe)

  6. Tenderness

    Time frame: 1 Week

    Tenderness 0-10 scale (10 most severe)

  7. Tenderness

    Time frame: 2 Weeks

    Tenderness 0-10 scale (10 most severe)

  8. Tenderness

    Time frame: 1 Month

    Tenderness 0-10 scale (10 most severe)

  9. Ecchymosis

    Time frame: 48 Hours post treatment (no baseline)

    0-5 scale (5 most severe) 0: None

    • <25%
    • 25-50%
    • 50-75%
    • 75-100%
    • Above or below treated (tx) segment

  10. Ecchymosis

    Time frame: 1 Week post treatment (no baseline)

    0-5 scale (5 most severe) 0: None

    • <25%
    • 25-50%
    • 50-75%
    • 75-100%
    • Above or below tx segment

  11. Ecchymosis

    Time frame: 2 Weeks post treatment (no baseline)

    0-5 scale (5 most severe) 0: None

    • <25%
    • 25-50%
    • 50-75%
    • 75-100%
    • Above or below tx segment

  12. Ecchymosis

    Time frame: 1 Month post treatment (no baseline)

    0-5 scale (5 most severe) 0: None

    • <25%
    • 25-50%
    • 50-75%
    • 75-100%
    • Above or below tx segment

  13. Complications

    Time frame: 1 month

    Sequelae at any follow-up

Secondary outcomes

  1. VCSS

    Time frame: 48 Hours

    Venous Clinical Severity Score (0-30 total overall score):

    0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

  2. VCSS

    Time frame: 1 Week

    Venous Clinical Severity Score (0-30 total overall score):

    0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

  3. VCSS

    Time frame: 2 Weeks

    Venous Clinical Severity Score (0-30 total overall score):

    0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

  4. VCSS

    Time frame: 1 Month

    Venous Clinical Severity Score (0-30 total overall score):

    0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease

  5. Change in CIVIQ QOL

    Time frame: 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

  6. Change in CIVIQ QOL

    Time frame: 1 Week

    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

  7. Change in CIVIQ QOL

    Time frame: 2 Week

    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

  8. Change in CIVIQ QOL

    Time frame: 1 Month

    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

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Collaborators

  • VNUS Medical Technologies, A Covidien Company

Registry information

Official study title

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

Acronym: RECOVERY

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 31, 2007
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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