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

August 15, 2017 updated by: Lovisenberg Diakonale Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0440
        • Lovisenberg Diakonale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) 3-4 years prior to study enrollment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vein obliteration or abolition of reflux
Time Frame: 3-4 years after treatment
As determined by duplex scanning
3-4 years after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent varicosities
Time Frame: 3-4 years after treatment
3-4 years after treatment
Recanalization
Time Frame: 3-4 years after treatment
3-4 years after treatment
Venous Clinical Severity Score
Time Frame: 3-4 years after treatment
3-4 years after treatment
Aberdeen Varicose Vein Questionnaire
Time Frame: 3-4 years after treatment
3-4 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 30, 2017

Study Completion (Anticipated)

September 30, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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