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

NCT ID: NCT02944331

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Varicose Veins

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovenous steam ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diakonale Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lovisenberg Diakonale Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Steam

Identifier Type: -

Identifier Source: org_study_id

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