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Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Primary Purpose

Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiofrequency
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible

Exclusion Criteria:

  • Exclusion criteria consisted of:
  • Current deep vein thrombosis (DVT)
  • Thrombus in the vein of interest
  • Previous GSV treatment
  • Pregnancy
  • Known malignancy
  • Significant arterial disease (ankle : brachial pressure index below 0•8)
  • Use of anticoagulant medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Sham Comparator

    Arm Label

    ClosureFast group

    group 1

    Arm Description

    Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux

    EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux

    Outcomes

    Primary Outcome Measures

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Secondary Outcome Measures

    Full Information

    First Posted
    March 4, 2014
    Last Updated
    April 2, 2014
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02080013
    Brief Title
    Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux
    Official Title
    Prospective, Randomized Study of Endovenous Segmental Radiofrequency Versus 1320 nm Laser Ablation for the Treatment of Great Saphenous Vein Reflux (RVLAb Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.
    Detailed Description
    Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicose Veins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ClosureFast group
    Arm Type
    Sham Comparator
    Arm Description
    Radiofrequency Ablation for the Treatment of Great Saphenous Vein Reflux
    Arm Title
    group 1
    Arm Type
    Sham Comparator
    Arm Description
    EVL group Endovenous Laser Ablation for the Treatment of Great Saphenous Vein Reflux
    Intervention Type
    Other
    Intervention Name(s)
    radiofrequency
    Other Intervention Name(s)
    ClosureFAST
    Intervention Description
    ClosureFAST
    Primary Outcome Measure Information:
    Title
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible Exclusion Criteria: Exclusion criteria consisted of: Current deep vein thrombosis (DVT) Thrombus in the vein of interest Previous GSV treatment Pregnancy Known malignancy Significant arterial disease (ankle : brachial pressure index below 0•8) Use of anticoagulant medication.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hossam M. Saleh, PhD
    Organizational Affiliation
    Vascular Surgery Department, Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

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