Varicose VeinsPhase 4NCT02010723
Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
A Phase 4 study testing surgery and sclerotherapy with aethoxysclerol foam in people with Varicose Veins, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- surgery and sclerotherapy with aethoxysclerol foam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2006to Feb 2012
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- reflux in anterior accessory great saphenous vein (AAGSV) > 0,5 sek
Who cannot join
- concomitant reflux in great saphenous vein (GSV)
- reflux in the deep venous system (postthrombotic syndrome)
- acute thrombosis
- hypercoagulability
- allergy to aethoxysclerol or local anesthetics
- immobility
Show all 10Show fewer
- open foramen ovale
- bacterial infection of the skin
- pregnancy and breast feeding
- peripheral arterial occlusive disease III, IV (PAOD)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of General Dermatology
Vienna, State of Vienna, 1090
About this study
Official title: Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.
- Conditions
- Varicose Veins
- Being tested
- surgery, sclerotherapy with aethoxysclerol foam
- Keywords
- varicosis, foam sclerotherapy, surgery
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
sclerotherapy with aethoxysclerol foamDrug
foam sclerotherapy with aethoxysclerol foam
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia Receives: Procedure: surgery |
| sclerotherapy | Experimental | foam sclerotherapy with aethoxysclerol foam Receives: Drug: sclerotherapy with aethoxysclerol foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
duplex-sonographic recurrence after 3 years
duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.
Measured: 3 years
Secondary outcomes (3)
duplex-sonographic recurrence after 1 year
duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the AAGSV in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group
Measured: 1 year
clinical recurrence
Clinical recurrence is evaluated by determination of the current Clinical-Etiology- Anatomy- Pathophysiology (CEAP) classification and reappearance of new varicose veins in the treated area
Measured: 1 year and 3 years
neovascularisation in the saphenofemoral junction
Measured: 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startJun 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornelia Boehler, Medical University of Vienna
- Investigators
- Kornelia Boehler, MD, Principal investigator, Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010723
- Sponsor's protocol ID
- 20060508
- Other IDs
- 255/2006
- Status last verified
- Dec 2013
- First submitted
- 18 Nov 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prinz N, Selzle K, Kamionek I, Sagoo KS, Leberig A, Kaiser R, Schonath M. [Surgery of the lateral accessory saphenous vein]. Zentralbl Chir. 2001 Jul;126(7):526-7. doi: 10.1055/s-2001-16280. German.
PubMed 11503465Breu FX, Guggenbichler S, Wollmann JC; Second European Consensus Meeting on Foam Sclerotherapy. Duplex ultrasound and efficacy criteria in foam sclerotherapy from the 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37(1):90-5. doi: 10.1024/0301-1526.37.1.90.
PubMed 18512547Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):477-81. doi: 10.1016/j.ejvs.2008.11.035. Epub 2009 Feb 7.
PubMed 19201621
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
- ClinicalTrials.gov ID
- NCT02010723
- Acronym / sponsor ID
- 20060508
- Conditions
- Varicose Veins
- Keywords
- varicosis, foam sclerotherapy, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Dec 2013 (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.
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: surgerycrossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia |
| sclerotherapy | Experimental | Drug: sclerotherapy with aethoxysclerol foamfoam sclerotherapy with aethoxysclerol foam |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- reflux in anterior accessory great saphenous vein (AAGSV) > 0,5 sek
Key exclusion criteria (10 listed)
- concomitant reflux in great saphenous vein (GSV)
- reflux in the deep venous system (postthrombotic syndrome)
- acute thrombosis
- hypercoagulability
- allergy to aethoxysclerol or local anesthetics
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 |
|---|---|---|
| surgerycrossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia | Procedure or surgery | surgery |
| sclerotherapy with aethoxysclerol foamfoam sclerotherapy with aethoxysclerol foam | Drug | sclerotherapy |
Primary outcome
duplex-sonographic recurrence after 3 years
Time frame: 3 years
duplex-sonographic recurrence is defined as reverse blood flow of > 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.
3 secondary outcomes
duplex-sonographic recurrence after 1 year
Time frame: 1 year
clinical recurrence
Time frame: 1 year and 3 years
neovascularisation in the saphenofemoral junction
Time frame: 1 year and 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 13 Dec 2013.
- Background: PubMed 11503465Prinz N, Selzle K, Kamionek I, Sagoo KS, Leberig A, Kaiser R, Schonath M. [Surgery of the lateral accessory saphenous vein]. Zentralbl Chir. 2001 Jul;126(7):526-7. doi: 10.1055/s-2001-16280. German.
- Background: PubMed 18512547Breu FX, Guggenbichler S, Wollmann JC; Second European Consensus Meeting on Foam Sclerotherapy. Duplex ultrasound and efficacy criteria in foam sclerotherapy from the 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37(1):90-5. doi: 10.1024/0301-1526.37.1.90.
- Background: PubMed 19201621Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):477-81. doi: 10.1016/j.ejvs.2008.11.035. Epub 2009 Feb 7.
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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.
Kornelia Boehler, MD principal investigator
Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing surgery and sclerotherapy with aethoxysclerol foam in people with Varicose Veins, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 10 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 13 Dec 2013. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duplex-sonographic recurrence after 3 years (time frame: 3 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 NCT02010723, which also lists 3 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 13 Dec 2013.