Varicose Veins of Lower LimbFOVELASSNCT05468450
RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency
A study testing Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant and Endovenous Laser Ablation (EVLA) in people with Varicose Veins of Lower Limb, run by Societe Francaise de Phlebologie.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant and Endovenous Laser Ablation (EVLA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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)
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.
Read the 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.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant, Endovenous Laser Ablation (EVLA)
- Keywords
- small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosantDrug
Also called Foam sclerotherapy
Direct injection Foam sclerotherapy
Endovenous Laser Ablation (EVLA)Device
Also called Laser therapy
EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided-foam sclerotherapy (UGFS) | Active comparator | Injection of Polidocanol foam into SSV Receives: Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant |
| Endovenous Laser Ablation (EVLA) | Active comparator | Ablation of SSV using laser energy Receives: Device: Endovenous Laser Ablation (EVLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of reflux in the treated SSV segment
closed veins or patent veins with no reflux (>0.5sec)
Measured: 3Assessed at years
Secondary outcomes (7)
Treatment time
Time (in minutes) spent in undertaking each treatment
Measured: Assessed on day of treatment
Procedure related complications
Any related complications arising from the procedure
Measured: Assessed through study completion, an average of 3 years
Periprocedural pain score
assessed on a visual analogue score (zero = no pain, 100 = maximum pain)
Measured: up to four weeks
Presence of visible varices
Reported recurrence of varicose veins
Measured: Through study completion, average of 3 years
Venous symptoms questionnaire
Validated questionnaire scores
Measured: Through study completion, average of 3 years
Revised Venous Clinical Severity Score -rVCSS
Validated questionnaire scores
Measured: Through study completion, average of 3 years
Quality of Life questionnaire (CIVIQ)
Validated questionnaire scores
Measured: Through study completion, average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Jul 2015
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Francaise de Phlebologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudine Hamel-Desnos, Study director, Institut des Varices- GHPJS Groupe HospitalierMatthieu Josnin, Principal investigator, Société Française de Phlébologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468450
- Sponsor's protocol ID
- 2014-A01943-44
- Acronym
- FOVELASS
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data.
Publications
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
Hamel-Desnos C, Nyamekye I, Chauzat B, Gracia S, Josnin M, Abbadie F. FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):415-423. doi: 10.1016/j.ejvs.2022.11.021. Epub 2022 Dec 5.
PubMed 36470312
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05468450
- Acronym / sponsor ID
- FOVELASS / 2014-A01943-44
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Societe Francaise de PhlebologieUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided-foam sclerotherapy (UGFS) | Active comparator | Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosantInjection of Polidocanol foam into SSV |
| Endovenous Laser Ablation (EVLA) | Active comparator | Device: Endovenous Laser Ablation (EVLA)Ablation of SSV using laser energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosantAlso: Foam sclerotherapyDirect injection Foam sclerotherapy | Drug | Ultrasound-guided-foam sclerotherapy (UGFS) |
| Endovenous Laser Ablation (EVLA)Also: Laser therapyEVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA) | Device | Endovenous Laser Ablation (EVLA) |
Primary outcome
Absence of reflux in the treated SSV segment
Time frame: 3Assessed at years
closed veins or patent veins with no reflux (>0.5sec)
7 secondary outcomes
Treatment time
Time frame: Assessed on day of treatment
Procedure related complications
Time frame: Assessed through study completion, an average of 3 years
Periprocedural pain score
Time frame: up to four weeks
Presence of visible varices
Time frame: Through study completion, average of 3 years
Venous symptoms questionnaire
Time frame: Through study completion, average of 3 years
Revised Venous Clinical Severity Score -rVCSS
Time frame: Through study completion, average of 3 years
Quality of Life questionnaire (CIVIQ)
Time frame: Through study completion, average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background9) 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
- Derived from this study: PubMed 36470312Hamel-Desnos C, Nyamekye I, Chauzat B, Gracia S, Josnin M, Abbadie F. FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):415-423. doi: 10.1016/j.ejvs.2022.11.021. Epub 2022 Dec 5.
- Individual participant dataSharing planned: No. Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudine Hamel-Desnos study director
Institut des Varices- GHPJS Groupe Hospitalier
Matthieu Josnin principal investigator
Société Française de Phlébologie
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant and Endovenous Laser Ablation (EVLA) in people with Varicose Veins of Lower Limb, run by Societe Francaise de Phlebologie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of reflux in the treated SSV segment (time frame: 3Assessed at years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468450, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.