- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00529672
Surgery or Noninvasive Therapy for Varicose Veins (Magna)
Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
Study Overview
Status
Conditions
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:
1. 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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Michael Kockaert, MD
- Phone Number: 31 10 4634580
- Email: m.kockaert@erasmusmc.nl
Study Contact Backup
- Name: Tamar Nijsten, MD, PhD
- Phone Number: 31 10 4631019
- Email: t.nijsten@erasmusmc.nl
Study Locations
-
-
-
Rotterdam, Netherlands, 3000 CA
- Recruiting
- Erasmus MC dermatology
-
Contact:
- Michael Kockaert, MD
- Phone Number: 31 10 4634580
- Email: m.kockaert@erasmusmc.nl
-
Contact:
- Tamar Nijsten, MD, PhD
- Phone Number: 31 10 4631019
- Email: t.nijsten@ersmusmc.nl
-
Sub-Investigator:
- Prof. sambeek, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary insufficient GSV confirmed by US: reflux>0.5 sec and diameter>0.5cm.
- non-treated insufficient GSV
- >18 years
- informed consent
Exclusion Criteria:
- acute thrombosis or phlebitis
- absence of deep venous system
- vascular syndromes
- use of anticoagulants
- contraindications surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Surgery: crossectomy plus short stripping
|
under spinal or complete anaesthesia
|
Active Comparator: 2
ultrasound guided sclerotherapy with foam (3% polidocanol)
|
1 part 3% polidocanol mixed with 3 parts of air.
Between 3cc - 12 cc per varicose vein>
|
Active Comparator: 3
Endovenous laser therapy (940 nm, about 70 J/cm)
|
940 nm Diode laser.
About 70 J/cm will be administered.
Disposables from Angiocare (registered) will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
anatomical success rate (absence or obliteration of GSV on US examination)
Time Frame: 3 months, 1 and 5 years
|
3 months, 1 and 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
treatment related adverse events and complications
Time Frame: 3 months, 1 and 5 years
|
3 months, 1 and 5 years
|
patient reported outcomes (HRQOL and treatment satisfaction)
Time Frame: 3 months, 1 and 5 years
|
3 months, 1 and 5 years
|
cost effectiveness analysis
Time Frame: 3 months, 1 and 5 years
|
3 months, 1 and 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martino Neumann, MD, PhD, Erasmus Medical Center
Publications and helpful links
General 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.
- Biemans 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-325
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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