Varicose VeinPhase 3MagnaNCT00529672
Surgery or Noninvasive Therapy for Varicose Veins
A Phase 3 study testing crossectomy and short stripping, ultrasound guided sclerotherapy with foam and endovenous laser therapy in people with Varicose Vein, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Vein
- What is being tested?
- crossectomy and short stripping, ultrasound guided sclerotherapy with foam and endovenous laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to May 2011
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary insufficient GSV confirmed by US: reflux>0.5 sec and diameter>0.5cm.
- non-treated insufficient GSV
- >18 years
- informed consent
Who cannot join
- acute thrombosis or phlebitis
- absence of deep venous system
- vascular syndromes
- use of anticoagulants
- contraindications surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC dermatology
Rotterdam, 3000 CA
Michael Kockaert, MD, 31 10 4634580, m.kockaert@erasmusmc.nl
Tamar Nijsten, MD, PhD, 31 10 4631019, t.nijsten@ersmusmc.nl
About this study
Official title: Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.
Read the detailed description
Inclusion criteria:
- Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm)
- non-treated GSV varicosis
- CEAP -classification > C2 and As2
- >18 years old
- Informed consent.
Exclusion criteria:
- Acute venous thrombosis / phlebitis
- Absence of deep venous system
- Vascular syndromes
- Post-thrombotic syndrome of occlusive type
- Contra-indications for surgery
- use of anticoagulants
Primary outcomes:
- anatomical success using US (absence of GSV or flow) (at 3 months, 1 and 5 year)
Secondary outcomes:
- treatment induced adverse events and complications (after 3 months)
- patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months)
- cost effectiveness analyses (after 1 and 5 years)
Included patients: total of 240 (80 per arm)
Study start: May 2007 (recruitment ongoing) Study completion: May 2011
Follow up after 3 months, 1, 2, 3, 4 and 5 years
Location: department of dermatology, Erasmus MC, Rotterdam, The Netherlands
Principle investigators: M. Kockaert, T. Nijsten \& M. Neumann
Publications:
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. Epub 2007 Jun 27.
Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg. 2007 Sep;21(5):551-5.
Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94.
Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C.Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007 Aug;94(8):925-36.
Subramonia S, Lees TA.The treatment of varicose veins.Ann R Coll Surg Engl. 2007 Mar;89(2):96-100.
Bohler K. Varicose veins: disfigurement or disease? Herz. 2007 Feb;32(1):18-25.
Bamigboye AA, Smyth R. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001066.
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. New endovenous therapies of truncal varicosities are more effective than surgical stripping and sclerotherapy: meta-analysis and meta-regression. Lancet, Submitted
- Conditions
- Varicose Vein
- Being tested
- crossectomy and short stripping, ultrasound guided sclerotherapy with foam, endovenous laser therapy
- Keywords
- endovenous laser therapy, sclerotherapy, crossectomy and stripping, surgery, treatment, 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.
crossectomy and short strippingProcedure or surgery
under spinal or complete anaesthesia
ultrasound guided sclerotherapy with foamProcedure or surgery
1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein>
endovenous laser therapyProcedure or surgery
940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgery: crossectomy plus short stripping Receives: Procedure: crossectomy and short stripping |
| 2 | Active comparator | ultrasound guided sclerotherapy with foam (3% polidocanol) Receives: Procedure: ultrasound guided sclerotherapy with foam |
| 3 | Active comparator | Endovenous laser therapy (940 nm, about 70 J/cm) Receives: Procedure: endovenous laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical success rate (absence or obliteration of GSV on US examination)
Measured: 3 months, 1 and 5 years
Secondary outcomes (3)
treatment related adverse events and complications
Measured: 3 months, 1 and 5 years
patient reported outcomes (HRQOL and treatment satisfaction)
Measured: 3 months, 1 and 5 years
cost effectiveness analysis
Measured: 3 months, 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
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 VeinStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Martino Neumann, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529672
- Sponsor's protocol ID
- 2005-325
- Acronym
- Magna
- Status last verified
- Nov 2010
- First submitted
- 13 Sep 2007
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, Neumann HA, Nijsten T, van den Bos RR. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. 2015 Sep;102(10):1184-94. doi: 10.1002/bjs.9867. Epub 2015 Jul 1.
PubMed 26132315Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
PubMed 23769603
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
- ClinicalTrials.gov ID
- NCT00529672
- Acronym / sponsor ID
- Magna / 2005-325
- Conditions
- Varicose Vein
- Keywords
- endovenous laser therapy, sclerotherapy, crossectomy and stripping, surgery, treatment, varicose veins
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 14 Sep 2007 (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.
For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.
Detailed description
Inclusion criteria:
- Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm)
- non-treated GSV varicosis
- CEAP -classification > C2 and As2
- >18 years old
- Informed consent.
Exclusion criteria:
- Acute venous thrombosis / phlebitis
- Absence of deep venous system
- Vascular syndromes
- Post-thrombotic syndrome of occlusive type
- Contra-indications for surgery
- use of anticoagulants
Primary outcomes:
- anatomical success using US (absence of GSV or flow) (at 3 months, 1 and 5 year)
Secondary outcomes:
- treatment induced adverse events and complications (after 3 months)
- patient reported outcomes (HRQOL and treatment satisfaction)(after 3 months)
- cost effectiveness analyses (after 1 and 5 years)
Included patients: total of 240 (80 per arm)
Study start: May 2007 (recruitment ongoing) Study completion: May 2011
Follow up after 3 months, 1, 2, 3, 4 and 5 years
Location: department of dermatology, Erasmus MC, Rotterdam, The Netherlands
Principle investigators: M. Kockaert, T. Nijsten \& M. Neumann
Publications:
Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaetz B, Eklof B. Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short-term results. J Vasc Surg. 2007 Aug;46(2):308-15. Epub 2007 Jun 27.
Sharif MA, Lau LL, Lee B, Hannon RJ, Soong CV. Role of endovenous laser treatment in the management of chronic venous insufficiency. Ann Vasc Surg. 2007 Sep;21(5):551-5.
Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of endovenous laser treatment for varicose veins. Br J Surg. 2005 Oct;92(10):1189-94.
Jia X, Mowatt G, Burr JM, Cassar K, Cook J, Fraser C.Systematic review of foam sclerotherapy for varicose veins. Br J Surg. 2007 Aug;94(8):925-36.
Subramonia S, Lees TA.The treatment of varicose veins.Ann R Coll Surg Engl. 2007 Mar;89(2):96-100.
Bohler K. Varicose veins: disfigurement or disease? Herz. 2007 Feb;32(1):18-25.
Bamigboye AA, Smyth R. Interventions for varicose veins and leg oedema in pregnancy. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001066.
van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. New endovenous therapies of truncal varicosities are more effective than surgical stripping and sclerotherapy: meta-analysis and meta-regression. Lancet, Submitted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: crossectomy and short strippingSurgery: crossectomy plus short stripping |
| 2 | Active comparator | Procedure: ultrasound guided sclerotherapy with foamultrasound guided sclerotherapy with foam (3% polidocanol) |
| 3 | Active comparator | Procedure: endovenous laser therapyEndovenous laser therapy (940 nm, about 70 J/cm) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- primary insufficient GSV confirmed by US: reflux>0.5 sec and diameter>0.5cm.
- non-treated insufficient GSV
- >18 years
- informed consent
Key exclusion criteria (5 listed)
- acute thrombosis or phlebitis
- absence of deep venous system
- vascular syndromes
- use of anticoagulants
- contraindications surgery
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 |
|---|---|---|
| crossectomy and short strippingunder spinal or complete anaesthesia | Procedure or surgery | 1 |
| ultrasound guided sclerotherapy with foam1 part 3% polidocanol mixed with 3 parts of air. Between 3cc - 12 cc per varicose vein> | Procedure or surgery | 2 |
| endovenous laser therapy940 nm Diode laser. About 70 J/cm will be administered. Disposables from Angiocare (registered) will be used. | Procedure or surgery | 3 |
Primary outcome
anatomical success rate (absence or obliteration of GSV on US examination)
Time frame: 3 months, 1 and 5 years
3 secondary outcomes
treatment related adverse events and complications
Time frame: 3 months, 1 and 5 years
patient reported outcomes (HRQOL and treatment satisfaction)
Time frame: 3 months, 1 and 5 years
cost effectiveness analysis
Time frame: 3 months, 1 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
- Derived from this study: PubMed 26132315van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, Neumann HA, Nijsten T, van den Bos RR. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg. 2015 Sep;102(10):1184-94. doi: 10.1002/bjs.9867. Epub 2015 Jul 1.
- Derived from this study: PubMed 23769603Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
Related trials for Varicose Vein
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
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.
Martino Neumann, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing crossectomy and short stripping, ultrasound guided sclerotherapy with foam and endovenous laser therapy in people with Varicose Vein, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 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: status not confirmed, as of the sponsor's last update on 16 Nov 2010. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Kockaert, MD (31 10 4634580, M.KOCKAERT@ERASMUSMC.NL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical success rate (absence or obliteration of GSV on US examination) (time frame: 3 months, 1 and 5 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 NCT00529672, 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 16 Nov 2010.