Chronic Venous Insufficiency C2 or HigherVNUS vs TULIPNCT01722019
Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
A study testing Tulip fiber and VNUS closure fast in people with Chronic Venous Insufficiency C2 or Higher, run by University Hospital, Ghent at 3 sites in Belgium.
Trial summary
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Venous Insufficiency C2 or Higher
- What is being tested?
- Tulip fiber and VNUS closure fast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jan 2014to 31 Aug 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endovenous ablation of the great saphenous vein (GSV) planned
- Patient signed informed consent
- Patient must complete the 1 year follow-up
- CEAP between 2 and 6
- BMI=<35
- Diameter of the GSV in upward position less than 20 mm diameter
- No problems in deep venous system
Who cannot join
- No informed consent is signed
- Latex allergy
- Arterial insufficiency
- Deep vein thrombosis or deep vein insufficiency
- Klippel Trenaunay
- Diameter fo GSV > 20 mm
Show all 16Show fewer
- Cross dilation with 2 or more insufficient side branches
- Previous GSV operation
- Redo-operation
- Carcinoma less than 1 year ago
- BMI > 35
- Liver-insufficiency with contraindication for local tumescence
- Intake of warfarins
- Pregnancy, breastfeeding, < 3 months after pregnancy
- Bilateral GSV insufficiency that has to be treated
- Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Ghent University Hospital
Ghent, 9000
University Hospital Leuven
Leuven, 3000
Sint-Andriesziekenhuis Tielt
Tielt, 8700
About this study
Official title: Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…
- Being tested
- Tulip fiber, VNUS closure fast
- Keywords
- venous insufficiency
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulip fiberDevice
Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
VNUS closure fastDevice
Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency ablation with VNUS closure fast | Active comparator | Radiofrequency ablation will be performed with VNUS closure fast. Receives: Device: VNUS closure fast |
| laser ablation and Tulip fiber | Experimental | Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber. Receives: Device: Tulip fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the greater saphenous vein at 12 months.
Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.
Measured: 12 months after procedure
Secondary outcomes (15)
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 5 days
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 14 days
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 1 month
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 6 months
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 1 year.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 5 days
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 14 days.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 1 month
Pain satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 6 months
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 1 year.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: after 5 days
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 14 days
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 1 month
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 6 months
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study start1 Jan 2014
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency C2 or HigherStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- European Venous Forum., Benelux Society of Phlebology.
- Responsible party
- Sponsor
- Investigators
- Carend Randon, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722019
- Sponsor's protocol ID
- 2012/693
- Acronym
- VNUS vs TULIP
- Status last verified
- Dec 2022
- First submitted
- 29 Oct 2012
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
- ClinicalTrials.gov ID
- NCT01722019
- Acronym / sponsor ID
- VNUS vs TULIP / 2012/693
- Keywords
- venous insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- European Venous Forum., Benelux Society of Phlebology.
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Nov 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.
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency ablation with VNUS closure fast | Active comparator | Device: VNUS closure fastRadiofrequency ablation will be performed with VNUS closure fast. |
| laser ablation and Tulip fiber | Experimental | Device: Tulip fiberLaser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Endovenous ablation of the great saphenous vein (GSV) planned
- Patient signed informed consent
- Patient must complete the 1 year follow-up
- CEAP between 2 and 6
- BMI=<35
Key exclusion criteria (16 listed)
- No informed consent is signed
- Latex allergy
- Arterial insufficiency
- Deep vein thrombosis or deep vein insufficiency
- Klippel Trenaunay
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 |
|---|---|---|
| Tulip fiberLaser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber. | Device | laser ablation and Tulip fiber |
| VNUS closure fastRadiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'. | Device | radiofrequency ablation with VNUS closure fast |
Primary outcome
Closure of the greater saphenous vein at 12 months.
Time frame: 12 months after procedure
Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.
15 secondary outcomes
Pain.
Time frame: after 5 days
Pain.
Time frame: after 14 days
Pain.
Time frame: after 1 month
Pain.
Time frame: after 6 months
Pain.
Time frame: after 1 year.
Patient satisfaction rate.
Time frame: after 5 days
Patient satisfaction rate.
Time frame: After 14 days.
Patient satisfaction rate.
Time frame: After 1 month
Pain satisfaction rate.
Time frame: After 6 months
Patient satisfaction rate.
Time frame: After 1 year.
Incapacity to work.
Time frame: after 5 days
Incapacity to work.
Time frame: After 14 days
Incapacity to work.
Time frame: After 1 month
Incapacity to work.
Time frame: After 6 months
Incapacity to work.
Time frame: After 1 year
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 29 Dec 2022.
- Related InfoLink provided by the sponsor.
Related trials for Chronic Venous Insufficiency C2 or Higher
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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.
Carend Randon, MD, PhD principal investigator
University Hospital, Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tulip fiber and VNUS closure fast in people with Chronic Venous Insufficiency C2 or Higher, run by University Hospital, Ghent at 3 sites in Belgium.
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 7 inclusion and 16 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 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Closure of the greater saphenous vein at 12 months. (time frame: 12 months after procedure). 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 29 Dec 2022.