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Clinical Trials/NL-OMON36499
NL-OMON36499
Completed
Phase 4

Endovenous laser ablation versus mechano-chemical endovenous ablation in the treatment of great saphenous incompetence: a multicentric, randomized controlled trial - Clari-Laser study

Rijnstate Ziekenhuis0 sites224 target enrollmentTBD
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Conditionsvaricose veins1000318410057165

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
varicose veins
Sponsor
Rijnstate Ziekenhuis
Enrollment
224
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial ended prematurely

Registry
who.int
Start Date
TBD
End Date
February 10, 2021
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Rijnstate Ziekenhuis

Eligibility Criteria

Inclusion Criteria

  • •1\. Primary great saphenous incompetence
  • •2\. C2\-C4 varicose veins
  • •3\. Ultrasound criteria have to be sufficient for endovenous therapy: diameter of the great saphenous vein \> 3mm and \< 12mm, not tortuous
  • •4\. Signed informed consent
  • •5\. Patient willing for follow\-up
  • •6\. Age \> 18 years and \< 80 years

Exclusion Criteria

  • •1\. Patient not capable for informed consent
  • •2\. Pregnancy and lactation
  • •3\. Surgical or endovenous therapy for ipsilateral varicose vein incompetence in history
  • •4\. Deep venous trombosis in treated leg
  • •5\. Use of oral anticoagulantia
  • •6\. Contraindications or allergy for sclerosant
  • •7\. Immobilisation
  • •8\. Coagulation disorders or increased risk of tromboembolic complications
  • •9\. Peripheral arterial disease, Fontaine 3\-4
  • •10\. Severe renal failure

Outcomes

Primary Outcomes

Not specified

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