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RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS)

Primary Purpose

Varicose Veins of Lower Limb

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant
Endovenous Laser Ablation (EVLA)
Sponsored by
Societe Francaise de Phlebologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins of Lower Limb focused on measuring small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic varicose veins (CEAP C2s-C6)
  • underlying isolated SSV incompetence (SSV reflux time>0.5sec on duplex ultrasound (DUS))
  • reflux involving at least 15 cm of proximal SSV
  • minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position)

Exclusion Criteria:

  • SSV treatment in the preceding 3 months
  • post-thrombotic disease
  • deep or superficial vein thrombosis of less than 3 months duration
  • coexistent ipsilateral GSV insufficiency
  • morbid obesity (BMI>40)
  • presence of significant arterial disease (ABPI<0.5)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ultrasound-guided-foam sclerotherapy (UGFS)

    Endovenous Laser Ablation (EVLA)

    Arm Description

    Injection of Polidocanol foam into SSV

    Ablation of SSV using laser energy

    Outcomes

    Primary Outcome Measures

    Absence of reflux in the treated SSV segment
    closed veins or patent veins with no reflux (>0.5sec)

    Secondary Outcome Measures

    Treatment time
    Time (in minutes) spent in undertaking each treatment
    Procedure related complications
    Any related complications arising from the procedure
    Periprocedural pain score
    assessed on a visual analogue score (zero = no pain, 100 = maximum pain)
    Presence of visible varices
    Reported recurrence of varicose veins
    Venous symptoms questionnaire
    Validated questionnaire scores
    Revised Venous Clinical Severity Score -rVCSS
    Validated questionnaire scores
    Quality of Life questionnaire (CIVIQ)
    Validated questionnaire scores

    Full Information

    First Posted
    July 13, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Societe Francaise de Phlebologie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05468450
    Brief Title
    RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency
    Acronym
    FOVELASS
    Official Title
    Three-year Outcomes of a RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS Study, by the French Society of Phlebology)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    August 31, 2016 (Actual)
    Study Completion Date
    August 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Societe Francaise de Phlebologie

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.
    Detailed Description
    Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence. To date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicose Veins of Lower Limb
    Keywords
    small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
    Masking
    None (Open Label)
    Masking Description
    Blinding of participants and investigators is not possible because of the obvious differences between the two treatments (a single mid-calf injection versus multiple injections for tumescent anaesthesia/laser precautions etc…). A blind third-party check was carried out, only at 3 years, and those assessors were completely independent of the study and blinded.
    Allocation
    Randomized
    Enrollment
    161 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound-guided-foam sclerotherapy (UGFS)
    Arm Type
    Active Comparator
    Arm Description
    Injection of Polidocanol foam into SSV
    Arm Title
    Endovenous Laser Ablation (EVLA)
    Arm Type
    Active Comparator
    Arm Description
    Ablation of SSV using laser energy
    Intervention Type
    Drug
    Intervention Name(s)
    Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant
    Other Intervention Name(s)
    Foam sclerotherapy
    Intervention Description
    Direct injection Foam sclerotherapy
    Intervention Type
    Device
    Intervention Name(s)
    Endovenous Laser Ablation (EVLA)
    Other Intervention Name(s)
    Laser therapy
    Intervention Description
    EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)
    Primary Outcome Measure Information:
    Title
    Absence of reflux in the treated SSV segment
    Description
    closed veins or patent veins with no reflux (>0.5sec)
    Time Frame
    3Assessed at years
    Secondary Outcome Measure Information:
    Title
    Treatment time
    Description
    Time (in minutes) spent in undertaking each treatment
    Time Frame
    Assessed on day of treatment
    Title
    Procedure related complications
    Description
    Any related complications arising from the procedure
    Time Frame
    Assessed through study completion, an average of 3 years
    Title
    Periprocedural pain score
    Description
    assessed on a visual analogue score (zero = no pain, 100 = maximum pain)
    Time Frame
    up to four weeks
    Title
    Presence of visible varices
    Description
    Reported recurrence of varicose veins
    Time Frame
    Through study completion, average of 3 years
    Title
    Venous symptoms questionnaire
    Description
    Validated questionnaire scores
    Time Frame
    Through study completion, average of 3 years
    Title
    Revised Venous Clinical Severity Score -rVCSS
    Description
    Validated questionnaire scores
    Time Frame
    Through study completion, average of 3 years
    Title
    Quality of Life questionnaire (CIVIQ)
    Description
    Validated questionnaire scores
    Time Frame
    Through study completion, average of 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: symptomatic varicose veins (CEAP C2s-C6) underlying isolated SSV incompetence (SSV reflux time>0.5sec on duplex ultrasound (DUS)) reflux involving at least 15 cm of proximal SSV minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position) Exclusion Criteria: SSV treatment in the preceding 3 months post-thrombotic disease deep or superficial vein thrombosis of less than 3 months duration coexistent ipsilateral GSV insufficiency morbid obesity (BMI>40) presence of significant arterial disease (ABPI<0.5)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudine Hamel-Desnos
    Organizational Affiliation
    Institut des Varices- GHPJS Groupe Hospitalier
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Matthieu Josnin
    Organizational Affiliation
    Société Française de Phlébologie
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data.
    Citations:
    Citation
    9) Hamel-Desnos C., Josnin M., Allaert F.-A. Etude contrôlée randomisée de l'efficacité du laser endoveineux (1470 nm) versus échosclérothérapie à la mousse dans le traitement de l'insuffisance de la petite veine saphène. Phlébologie 2019 (72): 8-18
    Results Reference
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    Learn more about this trial

    RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency

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