- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02046967
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins (LAST)
January 27, 2014 updated by: RR van den Bos, Erasmus Medical Center
Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate.
It works by heating and thereby obliterating the vein.
Steam ablation is a new therapy that also works by heating and thereby obliterating the vein.
The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).
Study Overview
Status
Completed
Detailed Description
The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins.
The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.
Study Type
Interventional
Enrollment (Actual)
237
Phase
- Not Applicable
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
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-
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Rotterdam, Netherlands, 3015 CA
- Erasmus MC
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients over 18 years old
- Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 s, and diameter of vein > 0.5 cm
- Symptoms of chronic venous insufficiency
- No prior treatment of the insufficient GSV
- Informed consent
Exclusion Criteria:
- Acute deep or superficial vein thrombosis
- Agenesis of deep vein system
- Vascular malformation or syndrome
- Post-thrombotic syndrome, occlusive type
- Pregnancy
- Immobility
- Allergy to lidocaine
- Arterial insufficiency
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Endovenous laser ablation
Endovenous laser ablation with 940 nm bare fiber.
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Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
Other Names:
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Active Comparator: Endovenous steam ablation
Endovenous steam ablation with steam vein sclerosis system.
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Endovenous steam ablation with steam vein sclerosis.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.
Time Frame: 52 weeks
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52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Time Frame: 12 weeks
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12 weeks
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Minor complications: ecchymosis, pain and hyperpigmentation.
Time Frame: 12 weeks
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12 weeks
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Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Time Frame: 12 weeks
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12 weeks
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Treatment satisfaction
Time Frame: 2 weeks
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2 weeks
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Pain score
Time Frame: 2 weeks
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2 weeks
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Venous Clinical Severity Score (VCSS)
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Renate R van den Bos, MD, PhD, Erasmus Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2009
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
January 23, 2014
First Submitted That Met QC Criteria
January 27, 2014
First Posted (Estimate)
January 28, 2014
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErasmusMC
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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