Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
231 participants
INTERVENTIONAL
2007-10-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
NCT02046967
Surgery or Noninvasive Therapy for Varicose Veins
NCT00529672
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
NCT02236338
Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy
NCT03416413
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
NCT02890563
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Operative treatment
vein stripping
Operative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
Laser ablation
Ultrasound guided laser ablation
Laser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
Foam sclerotherapy
Ultrasound guided foam sclerotherapy
Foam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Operative treatment
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
Laser ablation
In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
Foam sclerotherapy
Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patient must be 20-70 years old
* degree of difficulty of vein insufficiency C2-C4
* average diameter of refluxing great saphenous vein 4 -10 mm
* patient is agreeable to the study
Exclusion Criteria
* lymphoedema
* severe concomitant disease
* venous ulcers or unclassified skin changes
* BMI more than 40
* pregnancy
* allergy to the foam used in sclerotherapy or to local anaesthetics
* coagulation disorder
* bilateral vein insufficiency (equal symptoms)
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helsinki University Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maarit Venermo
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maarit Venermo, MD,PhD
Role: STUDY_DIRECTOR
Department of Vascular Surgery, Helsinki University Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, Finland
Department of Vascular Surgery, Tampere University Hospital
Tampere, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vahaaho S, Halmesmaki K, Alback A, Saarinen E, Venermo M. Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins. Br J Surg. 2018 May;105(6):686-691. doi: 10.1002/bjs.10757.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Version 1.0 - Sep 6th, 2006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.