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NCT02944331 Clinical Trial

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

Varicose Veins Clinical Trial

Official title:
3-4 Year Outcomes Following Endovenous Steam Ablation of the Saphenous Veins for the Treatment of Venous Insufficiency

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02944331
Other study ID # Steam
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 24, 2016
Last updated August 15, 2017
Start date January 1, 2017
Est. completion date September 30, 2017

Study information
Verified date August 2017
Source Lovisenberg Diakonale Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the long-term effects of endovenous steam ablation (EVSA). Postoperative data at 3-4 year follow-up will be collected from patients treated with EVSA.

Description:

Endovenous steam ablation (EVSA) of saphenous veins (saphenous vein reflux) is one of the endothermal methods in the modern treatment of venous insufficiency. Good results and long-term follow-up have been published for endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), while long-term effects of EVSA are less documented. Therefore, the aim of this study is to evaluate the effect of EVSA in 200 consecutive patients treated with EVSA and conduct prospective evaluations at 3-4 year follow-up. Standardized and validated measures will be compared to preoperative measures to evaluate change in patient-reported and clinical outcomes over time.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endovenous steam ablation

Locations
Country Name City State
Norway Lovisenberg Diakonale Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vein obliteration or abolition of reflux As determined by duplex scanning 3-4 years after treatment
Secondary Recurrent varicosities 3-4 years after treatment
Secondary Recanalization 3-4 years after treatment
Secondary Venous Clinical Severity Score 3-4 years after treatment
Secondary Aberdeen Varicose Vein Questionnaire 3-4 years after treatment
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