3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02944331
• Date of registration: 24/10/2016
• Prospective Registration: Yes
• Primary sponsor: Lovisenberg Diakonale Hospital
• Public title: 3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency
• Scientific title: 3-4 Year Outcomes Following Endovenous Steam Ablation of the Saphenous Veins for the Treatment of Venous Insufficiency
• Date of first enrolment: January 1, 2017
• Target sample size: 200
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT02944331
• Study type: Observational
• Phase: N/A

Countries of recruitment

Norway

Key inclusion & exclusion criteria

Inclusion Criteria:

- Received steam ablation for treatment of saphenous vein reflux (clinical classes
C2-C4) at Lovisenberg Diakonale Hospital 3-4 years (i.e, 36-48 months) prior to study
enrollment.

- Ability to speak, understand, read, and write Norwegian in order to complete follow-up
exams and questionnaires.

Exclusion Criteria:

- <18 years of age



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Varicose Veins

Intervention(s)

Procedure: Endovenous steam ablation

Primary Outcome(s)

Vein obliteration or abolition of reflux [Time Frame: 3-4 years after treatment]

Secondary Outcome(s)

Venous Clinical Severity Score [Time Frame: 3-4 years after treatment]

Aberdeen Varicose Vein Questionnaire [Time Frame: 3-4 years after treatment]

Recanalization [Time Frame: 3-4 years after treatment]

Recurrent varicosities [Time Frame: 3-4 years after treatment]

Secondary ID(s)

Steam

Source(s) of Monetary Support

Please refer to primary and secondary sponsors