Varicose VeinsCOLANCT01637181
Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins
A study testing Endovenous laser ablation (EVLA) in people with Varicose Veins and Insufficiency of Great Saphenous Vein, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Insufficiency of Great Saphenous Vein
- What is being tested?
- Endovenous laser ablation (EVLA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Dec 2014
- 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 sec, and diameter of vein > 0.5 cm
- Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
- 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
Show all 9Show fewer
- Allergy to lidocaine
- Arterial insufficiency
- Diameter of GSV ≤ 0.5 mm at puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins
A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.
Read the detailed description
- Study type: Interventional. Randomized comparative clinical trial..
- Outcome measures:
- Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
- Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
- Outcome measures time frame:
Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.
- Focus of the study: Varicose great saphenous veins (GSV)
- Intervention information:
- Intervention name: endovenous laser ablation (EVLA)
- Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
- Arm information: both interventions are active comparators.
- Locations:
Rotterdam, Zuid-Holland, The Netherlands
- Being tested
- Endovenous laser ablation (EVLA)
- 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 (EVLA)Procedure or surgery
EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.
| Study group | Role | What they receive |
|---|---|---|
| EVLA 940 nm | Active comparator | Not described Receives: Procedure: Endovenous laser ablation (EVLA) |
| EVLA 1470 nm | Active comparator | Not described Receives: Procedure: Endovenous laser ablation (EVLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score and use of painkillers
A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.
Measured: 1 week post treatment
Treatment satisfaction
A NRS of satisfaction is filled in by the patient.
Measured: 1 week post treatment
Health related quality of life
Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.
Measured: 0 and 12 weeks post treatment
Secondary outcomes (2)
Number of participants with adverse events
Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Measured: The adverse events will be assessed at 1 and 12 weeks post treatment.
Occlusion of the treated GSV (effectiveness)
Obliteration of varicose vein and/or absence of reflux (>0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
Measured: The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionDec 2014
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Malskat, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637181
- Sponsor's protocol ID
- NL38160.078.11
- Acronym
- COLA
- Status last verified
- Feb 2015
- First submitted
- 18 Jun 2012
- Last updated
- 11 Feb 2015
- Results posted
- No
Publications
Malskat WS, Giang J, De Maeseneer MG, Nijsten TE, van den Bos RR. Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence. Br J Surg. 2016 Feb;103(3):192-8. doi: 10.1002/bjs.10035. Epub 2015 Dec 14.
PubMed 26661521
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins
- ClinicalTrials.gov ID
- NCT01637181
- Acronym / sponsor ID
- COLA / NL38160.078.11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2012 (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.
A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.
Detailed description
- Study type: Interventional. Randomized comparative clinical trial..
- Outcome measures:
- Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
- Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
- Outcome measures time frame:
Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.
- Focus of the study: Varicose great saphenous veins (GSV)
- Intervention information:
- Intervention name: endovenous laser ablation (EVLA)
- Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
- Arm information: both interventions are active comparators.
- Locations:
Rotterdam, Zuid-Holland, The Netherlands
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVLA 940 nm | Active comparator | Procedure: Endovenous laser ablation (EVLA) |
| EVLA 1470 nm | Active comparator | Procedure: Endovenous laser ablation (EVLA) |
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 sec, and diameter of vein > 0.5 cm
- Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
- No prior treatment of the insufficient GSV
- Informed consent
Key exclusion criteria (9 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 (EVLA)EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light. | Procedure or surgery | EVLA 1470 nm, EVLA 940 nm |
Primary outcome
Pain score and use of painkillers
Time frame: 1 week post treatment
A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.
Treatment satisfaction
Time frame: 1 week post treatment
A NRS of satisfaction is filled in by the patient.
Health related quality of life
Time frame: 0 and 12 weeks post treatment
Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.
2 secondary outcomes
Number of participants with adverse events
Time frame: The adverse events will be assessed at 1 and 12 weeks post treatment.
Occlusion of the treated GSV (effectiveness)
Time frame: The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.
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 11 Feb 2015.
- Derived from this study: PubMed 26661521Malskat WS, Giang J, De Maeseneer MG, Nijsten TE, van den Bos RR. Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence. Br J Surg. 2016 Feb;103(3):192-8. doi: 10.1002/bjs.10035. Epub 2015 Dec 14.
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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?
A study testing Endovenous laser ablation (EVLA) in people with Varicose Veins and Insufficiency of Great Saphenous Vein, 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 9 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 11 Feb 2015. 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?
Pain score and use of painkillers (time frame: 1 week post treatment). The study lists 3 primary outcomes in all. 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 NCT01637181, 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 11 Feb 2015.