Varicose Veins LegTYPERNCT06962813
Transdermal Radiofrequency V ERASER Versus Polidocanol Sclerotherapy for Reticular Veins and Telangiectasias
A study testing Radiofrequency V Eraser in people with Varicose Veins Leg and Telangiectasias, run by Science Valley Research Institute at 1 site in Brazil.
Trial summary
This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Veins Leg, Telangiectasias
- What is being tested?
- Radiofrequency V Eraser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2023to 10 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients willing to sign informed consent
- Patients from 18 to 80 years old with CVD classified as CEAP clinical classes C1 to C5, but only telangiectasias and reticular veins not connected to larger varicosities
Who cannot join
- Patients with great saphenous or small saphenous vein insufficiency.
- Patients with allergies to polidocanol
- Patients with contraindications to treat varicose veins
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital São Luiz Gonzaga and Hospital da Irmandade Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 02276-140
About this study
Official title: Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)
This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs
Read the detailed description
Chronic Venous Disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. Sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. The V Eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions.
Methods: This was a prospective, randomized, and comparative study comparing V Eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. Forty-one patients were randomized to either V Eraser or polidocanol sclerotherapy and underwent a single treatment session. Efficacy was assessed using the Aberdeen Varicose Vein Questionnaire and vessel clearance analysis in pre- and post-treatment images.
- Conditions
- Varicose Veins Leg, Telangiectasias
- Being tested
- Radiofrequency V Eraser
- Keywords
- radiofrequency, sclerotherapy, varicose veins
- Medical subject headings
- Telangiectasis, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency V EraserProcedure or surgery
standar of care sclerotherapy
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency V Eraser | Experimental | radiofrequency Receives: Procedure: Radiofrequency V Eraser |
| Polidocanol sclerotherapy | Active comparator | Standard of care, varicose veins, sclerotherapy Receives: Procedure: Radiofrequency V Eraser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic analysis
Image analysis of photos was performed on day 30. Using the ImageJ software, two blinded evaluators analyzed the pre- and post-procedure photographs, measuring the vessel lengths in both images
Measured: 30 days
Aberdeen AVVQ questionnaire
The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start10 Jan 2023
- Primary completion2 Jan 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins LegStudies 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
- Model description
- 2 arm parallel study
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science Valley Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Ramacciotti, Science Valley Research Institute
- Investigators
- Rebeca Higino, MD, Principal investigator, Faculty of Medical Sciences of Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962813
- Sponsor's protocol ID
- TYPER TRIAL
- Acronym
- TYPER
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moreno-Moraga J, Pascu ML, Alcolea JM, Smarandache A, Royo J, David F, Trelles MA. Effects of 1064-nm Nd:YAG long-pulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci. 2019 Sep;34(7):1325-1332. doi: 10.1007/s10103-019-02736-1. Epub 2019 Feb 1.
PubMed 30707327Siribumrungwong B, Noorit P, Reanpang T, Pornwaragorn C, Wilasrusmee C, Wongsuwanich S, Srikuea K, Orrapin S, Benyakorn T, Garratt AM, Rerkaserm K. Reliability, validity, and minimal clinically important differences for the Thai-version of the Aberdeen Varicose Vein Questionnaire (AVVQ-Thai) in patients with chronic venous disease. F1000Res. 2024 Oct 11;13:486. doi: 10.12688/f1000research.147716.2. eCollection 2024.
PubMed 39925999Diken AI, Alemdaroglu U, Ozyalcin S, Hafez I, Tunel HA, Yalcinkaya A, Ecevit AN. Adjuvant radiofrequency thermocoagulation improves the outcome of liquid sclerotherapy in the treatment of spider veins of the leg: A pilot study. Phlebology. 2021 Sep;36(8):620-626. doi: 10.1177/02683555211006534. Epub 2021 Apr 4.
PubMed 33813962Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8.
PubMed 26580877Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):231-261.e6. doi: 10.1016/j.jvsv.2022.09.004. Epub 2022 Oct 12.
PubMed 36326210
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)
- ClinicalTrials.gov ID
- NCT06962813
- Acronym / sponsor ID
- TYPER / TYPER TRIAL
- Conditions
- Varicose Veins Leg, Telangiectasias
- Keywords
- radiofrequency, sclerotherapy, varicose veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Science Valley Research InstituteUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 8 May 2025 (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.
This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs
Detailed description
Chronic Venous Disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. Sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. The V Eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions.
Methods: This was a prospective, randomized, and comparative study comparing V Eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. Forty-one patients were randomized to either V Eraser or polidocanol sclerotherapy and underwent a single treatment session. Efficacy was assessed using the Aberdeen Varicose Vein Questionnaire and vessel clearance analysis in pre- and post-treatment images.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm parallel study
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency V Eraser | Experimental | Procedure: Radiofrequency V Eraserradiofrequency |
| Polidocanol sclerotherapy | Active comparator | Procedure: Radiofrequency V EraserStandard of care, varicose veins, sclerotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing to sign informed consent
- Patients from 18 to 80 years old with CVD classified as CEAP clinical classes C1 to C5, but only telangiectasias and reticular veins not connected to larger varicosities
Key exclusion criteria (3 listed)
- Patients with great saphenous or small saphenous vein insufficiency.
- Patients with allergies to polidocanol
- Patients with contraindications to treat varicose veins
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 V Eraserstandar of care sclerotherapy | Procedure or surgery | Polidocanol sclerotherapy, Radiofrequency V Eraser |
Primary outcome
Photographic analysis
Time frame: 30 days
Image analysis of photos was performed on day 30. Using the ImageJ software, two blinded evaluators analyzed the pre- and post-procedure photographs, measuring the vessel lengths in both images
Aberdeen AVVQ questionnaire
Time frame: 30 days
The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30
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 8 May 2025.
- Background: PubMed 30707327Moreno-Moraga J, Pascu ML, Alcolea JM, Smarandache A, Royo J, David F, Trelles MA. Effects of 1064-nm Nd:YAG long-pulse laser on polidocanol microfoam injected for varicose vein treatment: a controlled observational study of 404 legs, after 5-year-long treatment. Lasers Med Sci. 2019 Sep;34(7):1325-1332. doi: 10.1007/s10103-019-02736-1. Epub 2019 Feb 1.
- Background: PubMed 39925999Siribumrungwong B, Noorit P, Reanpang T, Pornwaragorn C, Wilasrusmee C, Wongsuwanich S, Srikuea K, Orrapin S, Benyakorn T, Garratt AM, Rerkaserm K. Reliability, validity, and minimal clinically important differences for the Thai-version of the Aberdeen Varicose Vein Questionnaire (AVVQ-Thai) in patients with chronic venous disease. F1000Res. 2024 Oct 11;13:486. doi: 10.12688/f1000research.147716.2. eCollection 2024.
- Background: PubMed 33813962Diken AI, Alemdaroglu U, Ozyalcin S, Hafez I, Tunel HA, Yalcinkaya A, Ecevit AN. Adjuvant radiofrequency thermocoagulation improves the outcome of liquid sclerotherapy in the treatment of spider veins of the leg: A pilot study. Phlebology. 2021 Sep;36(8):620-626. doi: 10.1177/02683555211006534. Epub 2021 Apr 4.
- Background: PubMed 26580877Key DJ. A Preliminary Study of a Transdermal Radiofrequency Device for Body Slimming. J Drugs Dermatol. 2015 Nov;14(11):1272-8.
- Background: PubMed 36326210Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2022 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part I. Duplex Scanning and Treatment of Superficial Truncal Reflux: Endorsed by the Society for Vascular Medicine and the International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2023 Mar;11(2):231-261.e6. doi: 10.1016/j.jvsv.2022.09.004. Epub 2022 Oct 12.
- Individual participant dataSharing planned: No
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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.
Rebeca Higino, MD principal investigator
Faculty of Medical Sciences of Santa Casa de São Paulo
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 V Eraser in people with Varicose Veins Leg and Telangiectasias, run by Science Valley Research Institute at 1 site in Brazil.
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 2 inclusion and 3 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 8 May 2025. 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 Brazil. 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?
Photographic analysis (time frame: 30 days). The study lists 2 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 NCT06962813, which also lists 5 linked publications.
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 8 May 2025.