Varicose VeinsNCT02454452
Comparison of Radiofrequency, Vein Stripping and CHIVA for Venous Insufficency
A study testing Radiofrequency, Saphenous vein stripping and CHIVA in people with Varicose Veins, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Radiofrequency, Saphenous vein stripping and CHIVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Aug 2017
- 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
- Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
- Age > 18 years
- Informed consent
Who cannot join
- Recurrent varicose veins
- Post-thrombotic syndrome.
- Patients with active malignancies or severe ischemic heart disease.
- Serious liver disease
- Thrombophilia.
- Serious psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.
Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.
Read the detailed description
A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.
The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.
Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.
- Conditions
- Varicose Veins
- Being tested
- Radiofrequency, Saphenous vein stripping, CHIVA
- Keywords
- Varicose Veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyProcedure or surgery
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
Saphenous vein strippingProcedure or surgery
Saphenous vein stripping
CHIVAProcedure or surgery
conservative hemodynamic treatment venous insufficiency
| Study group | Role | What they receive |
|---|---|---|
| Saphenous vein stripping | Active comparator | Saphenous venous stripping surgical technique Receives: Procedure: Saphenous vein stripping |
| CHIVA | Active comparator | conservative hemodynamic treatment venous insufficiency (CHIVA) Receives: Procedure: CHIVA |
| Radiofrequency | Experimental | Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter Receives: Procedure: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of venous reflux
Absence of venous reflux by duplex ultrasound
Measured: 2 years
Secondary outcomes (4)
CIVIQ
Venous quality of Life questionnaire - Spanish validated version
Measured: 2 years
SF-36
Measured: 2 years
VCSS
Venous Clinical Severity Score
Measured: 2 years
Surgical complications
Hematoma, echymosis, infection, bleeding, induration, neuritic pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena González Cañas, Corporacion Parc Tauli
- Investigators
- Elena González Cañas, MD, Principal investigator, Corporacion Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454452
- Sponsor's protocol ID
- CEIC 2012/068
- Status last verified
- Aug 2017
- First submitted
- 22 May 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzalez Canas E, Florit Lopez S, Vilagut RV, Guevara-Noriega KA, Santos Espi M, Rios J, Soto SN, Gimenez Gaibar A. A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):101-112. doi: 10.1016/j.jvsv.2020.04.019. Epub 2020 Apr 28.
PubMed 32353592
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.
- ClinicalTrials.gov ID
- NCT02454452
- Acronym / sponsor ID
- CEIC 2012/068
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.
Detailed description
A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.
The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.
Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saphenous vein stripping | Active comparator | Procedure: Saphenous vein strippingSaphenous venous stripping surgical technique |
| CHIVA | Active comparator | Procedure: CHIVAconservative hemodynamic treatment venous insufficiency (CHIVA) |
| Radiofrequency | Experimental | Procedure: RadiofrequencyRadiofrequency treatment applied to the vein with VNUS Closure Fast catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
- Age > 18 years
- Informed consent
Key exclusion criteria (6 listed)
- Recurrent varicose veins
- Post-thrombotic syndrome.
- Patients with active malignancies or severe ischemic heart disease.
- Serious liver disease
- Thrombophilia.
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 |
|---|---|---|
| RadiofrequencyRadiofrequency treatment applied to the vein with VNUS Closure Fast catheter | Procedure or surgery | Radiofrequency |
| Saphenous vein strippingSaphenous vein stripping | Procedure or surgery | Saphenous vein stripping |
| CHIVAconservative hemodynamic treatment venous insufficiency | Procedure or surgery | CHIVA |
Primary outcome
Absence of venous reflux
Time frame: 2 years
Absence of venous reflux by duplex ultrasound
4 secondary outcomes
CIVIQ
Time frame: 2 years
SF-36
Time frame: 2 years
VCSS
Time frame: 2 years
Surgical complications
Time frame: 1 month
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 22 Aug 2017.
- Derived from this study: PubMed 32353592Gonzalez Canas E, Florit Lopez S, Vilagut RV, Guevara-Noriega KA, Santos Espi M, Rios J, Soto SN, Gimenez Gaibar A. A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):101-112. doi: 10.1016/j.jvsv.2020.04.019. Epub 2020 Apr 28.
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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.
Elena González Cañas, MD principal investigator
Corporacion Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency, Saphenous vein stripping and CHIVA in people with Varicose Veins, run by Corporacion Parc Tauli at 1 site in Spain.
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 3 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 venous reflux (time frame: 2 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 NCT02454452, which also lists 1 linked publication.
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 22 Aug 2017.