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
132 participants
INTERVENTIONAL
2014-01-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins
NCT01936168
PREservation Versus Thermal Ablation
NCT04034329
Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation
NCT04006184
Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
NCT05372146
Primary Insufficiency of the GSV With a Diameter >/= 12 mm, Antero-lateral Branches, or Below the Knee
NCT02345018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.
The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.
During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.
At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.
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
Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MOCA
The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).
MOCA
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
EVLA
The refluxing GSV was treated with endovenous laser ablation.
EVLA
Great saphenous vein occlusion with a thermal laser chateter
RFA
The refluxing GSV was treated with radiofrequency ablation.
RFA
Great saphenous vein occlusion with a thermal radiofrequency chateter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MOCA
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
EVLA
Great saphenous vein occlusion with a thermal laser chateter
RFA
Great saphenous vein occlusion with a thermal radiofrequency chateter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ultrasound-verified reflux in the GSV
* mean GSV diameter in the thigh between 5 and 12 millimetres
* informed consent.
Exclusion Criteria
* peripheral arterial disease
* lymphoedema
* pregnancy
* allergy to either the sclerosant or lidocaine
* severe general illness
* malignancy
* previous deep venous thrombosis
* previous varicose vein intervention in the same leg
* coagulation disorders
20 Years
75 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
Professor of Vascular Surgery
References
Explore related publications, articles, or registry entries linked to this study.
Vahaaho S, Halmesmaki K, Mahmoud O, Alback A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):652-659. doi: 10.1016/j.jvsv.2020.08.007. Epub 2020 Aug 12.
Vahaaho S, Mahmoud O, Halmesmaki K, Alback A, Noronen K, Vikatmaa P, Aho P, Venermo M. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019 Apr;106(5):548-554. doi: 10.1002/bjs.11158.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Clarivein RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.