Varicose Veins of Lower LimbNCT04526626
Endovenous RFA Versus Ligation and Striping for Varicose Veins
A study testing Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic) in people with Varicose Veins of Lower Limb, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial summary
Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jun 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of long saphenous varicose veins
Who cannot join
- Contraindicated to operation due to severe comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site
University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, 518053
About this study
Official title: Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial
Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)
- Keywords
- Radiofrequency ablation, High ligation and striping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)Device
Also called ClosureFast, Medtronic
Thermal injury to long saphenous vein
| Study group | Role | What they receive |
|---|---|---|
| High ligation and stripping | Experimental | High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins Receives: Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Occlusion of the long saphenous vein
Measured: up to 24 months
Complications
Deep vein thrombosis, skin burn
Measured: 2 weeks after operation
Recurrence of varicose vein
Recurrence of varicose vein
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start1 Feb 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hailei Li, M.D, Ph.D, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526626
- Sponsor's protocol ID
- HKUSZH201901013
- Status last verified
- Aug 2020
- First submitted
- 25 Mar 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT04526626
- Acronym / sponsor ID
- HKUSZH201901013
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- Radiofrequency ablation, High ligation and striping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 26 Aug 2020 (actual)
- 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.
Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High ligation and stripping | Experimental | Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of long saphenous varicose veins
Key exclusion criteria (1 listed)
- Contraindicated to operation due to severe comorbidities
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 for treatment of lower limb varicose veins (ClosureFast, Medtronic)Also: ClosureFast, MedtronicThermal injury to long saphenous vein | Device | High ligation and stripping |
Primary outcome
Technical success
Time frame: up to 24 months
Occlusion of the long saphenous vein
Complications
Time frame: 2 weeks after operation
Deep vein thrombosis, skin burn
Recurrence of varicose vein
Time frame: up to 24 months
Recurrence of varicose vein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Varicose Veins of Lower Limb
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Recruiting
Subfascial Endoscopic Perforator Surgery (SEPS) Versus Open Ligation for Lower Limb Varicose Veins
Varicose Veins of Lower Limb
Active, not recruitingObservational study
Prevalence of Pelvic Venous Congestion Syndrome in Female Patients With Lower Extremity Varicose Veins and Its Impact on Postoperative Quality of Life Improvement Following Radiofrequency Ablation: A Single-Center Prospective Cohort Study（PCSRFStudy）
Pelvic Venous Congestion Syndrome, Lower Limb Varicose Veins
RecruitingObservational study
Registry for Chronic Venous Disease Incidence and Natural Course
Varicose Veins of Lower Limb
Active, not recruitingObservational study
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
Varicose Veins of Lower Limb, Thromboses, Venous
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.
Hailei Li, M.D, Ph.D principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic) in people with Varicose Veins of Lower Limb, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2020. 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 China. 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?
Results are not available in the source record.
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?
Technical success (time frame: up to 24 months). 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?
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 26 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.