NCT03340246|Unknown
Delayed or Immediate Local Treatment of Veins
DELICATVE
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DELICATVE
Sponsor study identifier
interventional
140
1 country
1
Study Start
May 4, 2016
Actual (reported)Primary Completion
December 20, 2020
Actual (reported)Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism. This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 4, 2016
Actual (reported)October 13, 2017
Actual (reported)November 13, 2017
Actual (reported)December 20, 2020
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Need for sclerotherapy
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. \>C2 will be eligible for treatment.
3 months
Patient satisfaction
3 months
Occlusion rate of great saphenous vein
36 months
Mechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Mechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Helsinki University Hospital
Helsinki, 00029, Finland
Karoliina Halmesmäki, M.D., Ph.D
Helsinki University Central Hospital
Maarit Venermo, M.D., Ph.D.
Helsinki University Central Hospital
First Submitted
October 13, 2017
First Posted
November 13, 2017
Study Start
May 4, 2016
Actual (reported)Primary Completion
December 20, 2020
Actual (reported)Calcium Dobesilate After Radiofrequency Ablation for Varicose Veins
Contact the study team to confirm eligibility.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 9, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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