Varicose VeinsNCT02944331
3-4 Year Outcomes Following Endovenous Steam Ablation for Venous Insufficiency
An observational study of Varicose Veins, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Endovenous steam ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2017to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) 3-4 years prior to study enrollment
Who may be able to join
- 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.
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- Endovenous steam ablation
- Keywords
- Steam ablation, Endothermal ablation, Varicose vein treatment, Venous insufficiency, Saphenous vein reflux, Recurrent varicosity
- Medical subject headings
- Varicose Veins, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous steam ablationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Vein obliteration or abolition of reflux
As determined by duplex scanning
Measured: 3-4 years after treatment
Secondary outcomes (4)
Recurrent varicosities
Measured: 3-4 years after treatment
Recanalization
Measured: 3-4 years after treatment
Venous Clinical Severity Score
Measured: 3-4 years after treatment
Aberdeen Varicose Vein Questionnaire
Measured: 3-4 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study start1 Jan 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944331
- Sponsor's protocol ID
- Steam
- Status last verified
- Aug 2017
- First submitted
- 24 Oct 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-4 Year Outcomes Following Endovenous Steam Ablation of the Saphenous Veins for the Treatment of Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02944331
- Acronym / sponsor ID
- Steam
- Conditions
- Varicose Veins
- Keywords
- Steam ablation, Endothermal ablation, Varicose vein treatment, Venous insufficiency, Saphenous vein reflux, Recurrent varicosity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received steam ablation for treatment of saphenous vein reflux (clinical classes C2-C4) 3-4 years prior to study enrollment
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovenous steam ablation | Procedure or surgery | – |
Primary outcome
Vein obliteration or abolition of reflux
Time frame: 3-4 years after treatment
As determined by duplex scanning
4 secondary outcomes
Recurrent varicosities
Time frame: 3-4 years after treatment
Recanalization
Time frame: 3-4 years after treatment
Venous Clinical Severity Score
Time frame: 3-4 years after treatment
Aberdeen Varicose Vein Questionnaire
Time frame: 3-4 years after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein obliteration or abolition of reflux (time frame: 3-4 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.