Varicose VeinsNCT02397226
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery
A study testing Radiofrequency ablation, High ligation/stripping and Radiofrequency ablation catheter in people with Varicose Veins and Venous Insufficiency, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial summary
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Veins, Venous Insufficiency
- What is being tested?
- Radiofrequency ablation, High ligation/stripping and Radiofrequency ablation catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2014to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Insufficient great saphenous vein
- Possible to treat with both radiofrequency ablation and high ligation/stripping
- Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6
Who cannot join
- Previous intervention in the affected leg
- Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
- Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
- Patient that is not able to perform plethysmography
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital Linköping
Linköping, Östergötland County, 58185
Vrinnevisjukhuset
Norrköping, Östergötland County, 60379
About this study
Official title: Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).
- Conditions
- Varicose Veins, Venous Insufficiency
- Being tested
- Radiofrequency ablation, High ligation/stripping, Radiofrequency ablation catheter, Tumescent anesthesia, General anesthesia
- Keywords
- Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping
- 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.
Radiofrequency ablationProcedure or surgery
High ligation/strippingProcedure or surgery
Also called Open surgery
Radiofrequency ablation catheterDevice
Also called Covidien ClosureFast Catheter (7cm)
Tumescent anesthesiaProcedure or surgery
General anesthesiaProcedure or surgery
Vein stripping catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Active comparator | Treatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia. Receives: Procedure: Radiofrequency ablation; Device: Radiofrequency ablation catheter; Procedure: Tumescent anesthesia |
| High ligation/stripping | Active comparator | Treatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia. Receives: Procedure: High ligation/stripping; Procedure: General anesthesia; Device: Vein stripping catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treated veins with recanalization using duplex.
Flow detected by duplex at the site of the treated vein.
Measured: 5 years
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Measured: 5 years
Prediction of treatment outcome using plethysmography with superficial shut-down.
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
Measured: 1 month postoperatively
Secondary outcomes (3)
VCSS score
The score of standardized examination protocol VCSS.
Measured: 5 years
AVVQ score
The score of disease specific questionnaire AVVQ
Measured: 5 years
EQ-5D score
The score of EQ-5D questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start1 Sep 2014
- Primary completion25 Nov 2021
- Study completion31 Dec 2026 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oskar Nelzén, University Hospital, Linkoeping
- Investigators
- Helene Zachrisson, Associate Professor, MD, Study chair, Linkoeping UniversityOskar Nelzén, MD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397226
- Sponsor's protocol ID
- Varicerstudien
- Status last verified
- Dec 2024
- First submitted
- 12 Mar 2015
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20.
PubMed 31959059
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
- ClinicalTrials.gov ID
- NCT02397226
- Acronym / sponsor ID
- Varicerstudien
- Conditions
- Varicose Veins, Venous Insufficiency
- Keywords
- Radiofrequency ablation, Plethysmography, Duplex ultrasound, High ligation/stripping
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2015 (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.
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Active comparator | Procedure: Radiofrequency ablation, Device: Radiofrequency ablation catheter, Procedure: Tumescent anesthesiaTreatment with radiofrequency ablation using radiofrequency ablation catheter. This intervention implies tumescent anesthesia. |
| High ligation/stripping | Active comparator | Procedure: High ligation/stripping, Procedure: General anesthesia, Device: Vein stripping catheterTreatment with high ligation/stripping using a vein stripping catheter. This intervention implies general anesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Insufficient great saphenous vein
- Possible to treat with both radiofrequency ablation and high ligation/stripping
- Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6
Key exclusion criteria (4 listed)
- Previous intervention in the affected leg
- Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
- Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
- Patient that is not able to perform plethysmography
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 |
|---|---|---|
| Radiofrequency ablation | Procedure or surgery | Radiofrequency ablation |
| High ligation/strippingAlso: Open surgery | Procedure or surgery | High ligation/stripping |
| Radiofrequency ablation catheterAlso: Covidien ClosureFast Catheter (7cm) | Device | Radiofrequency ablation |
| Tumescent anesthesia | Procedure or surgery | Radiofrequency ablation |
| General anesthesia | Procedure or surgery | High ligation/stripping |
| Vein stripping catheter | Device | High ligation/stripping |
Primary outcome
Number of treated veins with recanalization using duplex.
Time frame: 5 years
Flow detected by duplex at the site of the treated vein.
Number of treated limbs with neovascularization using duplex and/or plethysmography.
Time frame: 5 years
Prediction of treatment outcome using plethysmography with superficial shut-down.
Time frame: 1 month postoperatively
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
3 secondary outcomes
VCSS score
Time frame: 5 years
AVVQ score
Time frame: 5 years
EQ-5D score
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 31959059Nelzen POE, Skoog J, Oster M, Zachrisson H. Impact on venous haemodynamics after treatment of great saphenous vein incompetence using plethysmography and duplex ultrasound. Phlebology. 2020 Aug;35(7):495-504. doi: 10.1177/0268355519898952. Epub 2020 Jan 20.
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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.
Helene Zachrisson, Associate Professor, MD study chair
Linkoeping University
Oskar Nelzén, MD principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation, High ligation/stripping and Radiofrequency ablation catheter in people with Varicose Veins and Venous Insufficiency, run by University Hospital, Linkoeping at 2 sites in Sweden.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of treated veins with recanalization using duplex. (time frame: 5 years). 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 NCT02397226, 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 6 Dec 2024.