NCT02944331

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

October 24, 2016

Last Update Submit

August 15, 2017

Conditions

Varicose Veins

Keywords

Steam ablationEndothermal ablationVaricose vein treatmentVenous insufficiencySaphenous vein refluxRecurrent varicosity

Outcome Measures

Primary Outcomes (1)

  • Vein obliteration or abolition of reflux

    As determined by duplex scanning

    3-4 years after treatment

Secondary Outcomes (4)

  • Recurrent varicosities

    3-4 years after treatment

  • Recanalization

    3-4 years after treatment

  • Venous Clinical Severity Score

    3-4 years after treatment

  • Aberdeen Varicose Vein Questionnaire

    3-4 years after treatment

Interventions

Endovenous steam ablationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

Location

MeSH Terms

Conditions

Varicose VeinsVenous Insufficiency

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 25, 2016

Study Start

January 1, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)