Varicose VeinsLASTNCT02046967
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
A study testing Endovenous laser ablation with 940 nm bare fiber and Endovenous steam ablation with steam vein sclerosis system. in people with Varicose Veins and Varicose Veins of Leg With Long Saphenous Vein Distribution, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Varicose Veins of Leg With Long Saphenous Vein Distribution
- What is being tested?
- Endovenous laser ablation with 940 nm bare fiber and Endovenous steam ablation with steam vein sclerosis system.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Mar 2013
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Endovenous laser ablation with 940 nm bare fiber, Endovenous steam ablation with steam vein sclerosis system.
- Keywords
- endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablation with 940 nm bare fiberProcedure or surgery
Also called EVLT, EVLA
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
Endovenous steam ablation with steam vein sclerosis system.Procedure or surgery
Also called SVS, EVSA
Endovenous steam ablation with steam vein sclerosis.
| Study group | Role | What they receive |
|---|---|---|
| Endovenous laser ablation | Active comparator | Endovenous laser ablation with 940 nm bare fiber. Receives: Procedure: Endovenous laser ablation with 940 nm bare fiber |
| Endovenous steam ablation | Active comparator | Endovenous steam ablation with steam vein sclerosis system. Receives: Procedure: Endovenous steam ablation with steam vein sclerosis system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (6)
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Measured: 12 weeks
Minor complications: ecchymosis, pain and hyperpigmentation.
Measured: 12 weeks
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Measured: 12 weeks
Treatment satisfaction
Measured: 2 weeks
Pain score
Measured: 2 weeks
Venous Clinical Severity Score (VCSS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startNov 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RR van den Bos, Erasmus Medical Center
- Investigators
- Renate R van den Bos, MD, PhD, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046967
- Sponsor's protocol ID
- ErasmusMC
- Acronym
- LAST
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30.
PubMed 24981585
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
- ClinicalTrials.gov ID
- NCT02046967
- Acronym / sponsor ID
- LAST / ErasmusMC
- Keywords
- endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Jan 2014 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovenous laser ablation | Active comparator | Procedure: Endovenous laser ablation with 940 nm bare fiberEndovenous laser ablation with 940 nm bare fiber. |
| Endovenous steam ablation | Active comparator | Procedure: Endovenous steam ablation with steam vein sclerosis system.Endovenous steam ablation with steam vein sclerosis system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Acute deep or superficial vein thrombosis
- Agenesis of deep vein system
- Vascular malformation or syndrome
- Post-thrombotic syndrome, occlusive type
- Pregnancy
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 laser ablation with 940 nm bare fiberAlso: EVLT, EVLAEndovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein. | Procedure or surgery | Endovenous laser ablation |
| Endovenous steam ablation with steam vein sclerosis system.Also: SVS, EVSAEndovenous steam ablation with steam vein sclerosis. | Procedure or surgery | Endovenous steam ablation |
Primary outcome
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
6 secondary outcomes
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Time frame: 12 weeks
Minor complications: ecchymosis, pain and hyperpigmentation.
Time frame: 12 weeks
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Time frame: 12 weeks
Treatment satisfaction
Time frame: 2 weeks
Pain score
Time frame: 2 weeks
Venous Clinical Severity Score (VCSS)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Derived from this study: PubMed 24981585van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30.
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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.
Renate R van den Bos, MD, PhD study director
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovenous laser ablation with 940 nm bare fiber and Endovenous steam ablation with steam vein sclerosis system. in people with Varicose Veins and Varicose Veins of Leg With Long Saphenous Vein Distribution, run by Erasmus Medical Center at 1 site in Netherlands.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jan 2014. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02046967, which also lists 1 linked publication.
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 28 Jan 2014.