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

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ClinicalTrials.gov Identifier: NCT00509392
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Venous Reflux Device: Seg. RF Ablation & ClosureFAST catheter Device: Endovenous Laser Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)
Study Start Date : March 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Seg. RF Ablation & ClosureFAST catheter
Seg. RF Ablation & ClosureFAST catheter
Device: Seg. RF Ablation & ClosureFAST catheter
Seg. RF Ablation & ClosureFAST catheter
Other Name: VNUS
Active Comparator: Endovenous Laser
Treatment invention of venous disease with an Endovenous Laser.
Device: Endovenous Laser
laser catheter
Other Name: Commercially approved laser catheter systems.


Outcome Measures

Primary Outcome Measures :
  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

    1. <25%
    2. 25-50%
    3. 50-75%
    4. 75-100%
    5. Above or below treated (tx) segment

  10. 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

  11. 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

  12. 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

  13. Complications [ Time Frame: 1 month ]
    Sequelae at any follow-up


Secondary Outcome Measures :
  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



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509392


Locations
United States, Oregon
Oregon Health Sciences
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Medtronic Endovascular
VNUS Medical Technologies, A Covidien Company
Investigators
Study Director: Lian Cunningham, MD VNUS Medical Technologies, A Covidien Company
More Information

Publications:
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00509392     History of Changes
Other Study ID Numbers: CVL-06-03
First Posted: July 31, 2007    Key Record Dates
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Medtronic Endovascular:
Varicose veins, venous reflux, GSV disease