Varicose Veins of Leg With Long Saphenous Vein DistributionPhase 4NCT07561320
Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein
A Phase 4 study testing Flebogrif and Polidocanol foam sclerotherapy in people with Varicose Veins of Leg With Long Saphenous Vein Distribution and Varicose Veins of Lower Limb, run by Antonio Eduardo Zerati at 1 site in Brazil.
Trial summary
This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein. Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins of Leg With Long Saphenous Vein Distribution, Varicose Veins of Lower Limb
- What is being tested?
- Flebogrif and Polidocanol foam sclerotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- May 2026to Nov 2027
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CEAP Classification C2, 3 or 4
- Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
Who cannot join
- Allergy to sclerosing substances
- Deep venous thrombosis, stroke, or pulmonary embolism
- Local or generalized infection at the sclerotherapy site
- Prolonged immobilization
- Asymptomatic patent foramen ovale
- Pregnancy Occlusive peripheral arterial disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital da Clínicas da FMUSP
São Paulo, São Paulo
Victor Minari Campos, MD, +5511997596010, victorminaricampos@gmail.com
Antonio Zerati, PhD
About this study
Official title: Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial
This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein.
Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments.
Read more
Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening.
In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate:
How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.
Read the detailed description
Introduction:
Ultrasound-guided foam sclerotherapy is a widely used method for the treatment of lower limb varicose veins. Its main advantages include applicability in patients at high surgical risk and immediate or early return to daily activities. However, it requires a higher number of reinterventions compared to other techniques due to increased rates of venous recanalization, particularly in larger-caliber veins. In contrast, mechanochemical ablation shares these advantages and is associated with lower recanalization rates.
Objective:
To compare ultrasound-guided foam sclerotherapy of the great saphenous vein (GSV) with mechanochemical ablation using the Flebogrif® catheter in the treatment of chronic venous insufficiency (CVI) associated with GSV disease. The primary endpoints will be quality of life assessment and GSV occlusion rate, as determined by lower limb venous color Doppler ultrasonography over the proposed follow-up period. Secondary endpoints include the incidence of treatment-related complications and pain level during the procedure.
Patients and Methods:
A total of 50 patients with primary varicose veins will be selected. Inclusion criteria include lower limb pain, edema, or skin changes such as hyperpigmentation, eczema, and lipodermatosclerosis (CEAP classification C2-C4, EpAsPr), as well as GSV insufficiency with a diameter between 6 and 12 mm measured at the mid-thigh using color Doppler ultrasonography. Clinical evaluations and ultrasound examinations will be conducted at the venous disease outpatient clinic, and procedures will be performed in the minor surgery operating room of the University of São Paulo Hospital.
This will be a prospective randomized study, with patients allocated into two groups according to the treatment technique.
Group 1: Percutaneous puncture and ultrasound-guided injection of sclerosant foam through a short 18G catheter.
Group 2: Use of the Flebogrif® catheter, positioned under ultrasound guidance 2 cm from the saphenofemoral junction, followed by catheter withdrawal combined with sclerosant foam injection.
In both groups, 20 mL of 0.9% saline solution will be infused prior to polidocanol administration. The GSV puncture site will depend on the extent of insufficiency (segmental or total), being performed at the knee or medial malleolar region, respectively, after local anesthesia with 2% lidocaine without vasoconstrictor and without infiltration along the venous course.
For knee-level puncture, a tourniquet will be applied distal to the access site and maintained for 5 minutes after foam injection to prevent dispersion into healthy venous segments.
In all patients, varicose tributaries will be treated immediately after the GSV procedure using 1% polidocanol sclerotherapy.
Expected Results:
Mechanochemical ablation is expected to demonstrate a higher target vein occlusion rate with lower recanalization rates, without increased procedural pain and with at least a comparable complication rate to ultrasound-guided foam sclerotherapy. This study aims to contribute to the refinement of treatment strategies, seeking greater efficacy with monotherapy.
- Being tested
- Flebogrif, Polidocanol foam sclerotherapy
- Keywords
- Mechanical chemical ablation, Flebogrif, Sclerotherapy with polidocanol foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlebogrifDevice
Mechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam.
Polidocanol foam sclerotherapyDrug
Polidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium.
| Study group | Role | What they receive |
|---|---|---|
| Great saphenous vein insufficiency (1) | Active comparator | 25 limbs with great saphenous vein insufficiency Receives: Device: Flebogrif; Drug: Polidocanol foam sclerotherapy |
| Great saphenous vein insufficiency (2) | Experimental | 25 limbs with great saphenous vein insufficiency Receives: Device: Flebogrif; Drug: Polidocanol foam sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire
Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire will be used. Score from 0 to 100, where 0 is the best and 100 is the worst quality of life related to varicose veins.
Measured: From enrollment to the end of treatment at 365 days after procedure
Disease Severity Score: Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) will be used. Score from 0 to 30, where 0 means asymptomatic patient and 30 means more symptomatic patient as possible.
Measured: From enrollment to the end of treatment at 365 days after procedure
Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006
Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006, will be used. Classification where 0 means reflux greater than 1 second, 1 means reflux less than 1 second, and 2 means no reflux.
Measured: From enrollment to the end of treatment at 365 days after procedure
Secondary outcomes (2)
Treatment complications
Deep vein thrombosis, thrombophlebitis, visual disturbances, skin irritation and skin hyperpigmentation.
Measured: One to 365 after procedure
Pain Level During Procedure: Visual Analog Pain Scale
Visual Analog Pain Scale will be used. Scale where 0 means no pain and 10 means maximum pain during procedure.
Measured: Pain level during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Leg With Long Saphenous Vein DistributionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized clinical trial including 50 patients with primary varicose veins and great saphenous vein (GSV) insufficiency (6-12 mm diameter, CEAP C2-C4). Patients will be randomized into two groups: ultrasound-guided foam sclerotherapy (Group 1) and mechanochemical ablation with the Flebogrif® catheter (Group 2).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antonio Eduardo Zerati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Eduardo Zerati, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561320
- Sponsor's protocol ID
- 83198024.0.0000.0068
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided. Maybe after publication.
Publications
Epstein D, Onida S, Bootun R, Ortega-Ortega M, Davies AH. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Health. 2018 Aug;21(8):911-920. doi: 10.1016/j.jval.2018.01.012. Epub 2018 Mar 15.
PubMed 30098668Petrone A, Peluso A, Ammollo RP, Turchino D, Del Guercio L, Andreucci M, Serra R, Bracale UM. Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience. Phlebology. 2022 Aug;37(7):522-528. doi: 10.1177/02683555221092194. Epub 2022 Apr 25.
PubMed 35466820Whing J, Nandhra S, Nesbitt C, Stansby G. Interventions for great saphenous vein incompetence. Cochrane Database Syst Rev. 2021 Aug 11;8(8):CD005624. doi: 10.1002/14651858.CD005624.pub4.
PubMed 34378180Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available.
PubMed 18277340
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07561320
- Acronym / sponsor ID
- 83198024.0.0000.0068
- Keywords
- Mechanical chemical ablation, Flebogrif, Sclerotherapy with polidocanol foam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Antonio Eduardo ZeratiUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 May 2026 (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 compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein.
Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments.
Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening.
In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate:
How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.
Detailed description
Introduction:
Ultrasound-guided foam sclerotherapy is a widely used method for the treatment of lower limb varicose veins. Its main advantages include applicability in patients at high surgical risk and immediate or early return to daily activities. However, it requires a higher number of reinterventions compared to other techniques due to increased rates of venous recanalization, particularly in larger-caliber veins. In contrast, mechanochemical ablation shares these advantages and is associated with lower recanalization rates.
Objective:
To compare ultrasound-guided foam sclerotherapy of the great saphenous vein (GSV) with mechanochemical ablation using the Flebogrif® catheter in the treatment of chronic venous insufficiency (CVI) associated with GSV disease. The primary endpoints will be quality of life assessment and GSV occlusion rate, as determined by lower limb venous color Doppler ultrasonography over the proposed follow-up period. Secondary endpoints include the incidence of treatment-related complications and pain level during the procedure.
Patients and Methods:
A total of 50 patients with primary varicose veins will be selected. Inclusion criteria include lower limb pain, edema, or skin changes such as hyperpigmentation, eczema, and lipodermatosclerosis (CEAP classification C2-C4, EpAsPr), as well as GSV insufficiency with a diameter between 6 and 12 mm measured at the mid-thigh using color Doppler ultrasonography. Clinical evaluations and ultrasound examinations will be conducted at the venous disease outpatient clinic, and procedures will be performed in the minor surgery operating room of the University of São Paulo Hospital.
This will be a prospective randomized study, with patients allocated into two groups according to the treatment technique.
Group 1: Percutaneous puncture and ultrasound-guided injection of sclerosant foam through a short 18G catheter.
Group 2: Use of the Flebogrif® catheter, positioned under ultrasound guidance 2 cm from the saphenofemoral junction, followed by catheter withdrawal combined with sclerosant foam injection.
In both groups, 20 mL of 0.9% saline solution will be infused prior to polidocanol administration. The GSV puncture site will depend on the extent of insufficiency (segmental or total), being performed at the knee or medial malleolar region, respectively, after local anesthesia with 2% lidocaine without vasoconstrictor and without infiltration along the venous course.
For knee-level puncture, a tourniquet will be applied distal to the access site and maintained for 5 minutes after foam injection to prevent dispersion into healthy venous segments.
In all patients, varicose tributaries will be treated immediately after the GSV procedure using 1% polidocanol sclerotherapy.
Expected Results:
Mechanochemical ablation is expected to demonstrate a higher target vein occlusion rate with lower recanalization rates, without increased procedural pain and with at least a comparable complication rate to ultrasound-guided foam sclerotherapy. This study aims to contribute to the refinement of treatment strategies, seeking greater efficacy with monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized clinical trial including 50 patients with primary varicose veins and great saphenous vein (GSV) insufficiency (6-12 mm diameter, CEAP C2-C4). Patients will be randomized into two groups: ultrasound-guided foam sclerotherapy (Group 1) and mechanochemical ablation with the Flebogrif® catheter (Group 2).
| Arm | Type | Receives |
|---|---|---|
| Great saphenous vein insufficiency (1) | Active comparator | Device: Flebogrif, Drug: Polidocanol foam sclerotherapy25 limbs with great saphenous vein insufficiency |
| Great saphenous vein insufficiency (2) | Experimental | Device: Flebogrif, Drug: Polidocanol foam sclerotherapy25 limbs with great saphenous vein insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CEAP Classification C2, 3 or 4
- Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
Key exclusion criteria (6 listed)
- Allergy to sclerosing substances
- Deep venous thrombosis, stroke, or pulmonary embolism
- Local or generalized infection at the sclerotherapy site
- Prolonged immobilization
- Asymptomatic patent foramen ovale
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 |
|---|---|---|
| FlebogrifMechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam. | Device | Great saphenous vein insufficiency (1), Great saphenous vein insufficiency (2) |
| Polidocanol foam sclerotherapyPolidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium. | Drug | Great saphenous vein insufficiency (1), Great saphenous vein insufficiency (2) |
Primary outcome
Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire
Time frame: From enrollment to the end of treatment at 365 days after procedure
Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire will be used. Score from 0 to 100, where 0 is the best and 100 is the worst quality of life related to varicose veins.
Disease Severity Score: Venous Clinical Severity Score (VCSS)
Time frame: From enrollment to the end of treatment at 365 days after procedure
Venous Clinical Severity Score (VCSS) will be used. Score from 0 to 30, where 0 means asymptomatic patient and 30 means more symptomatic patient as possible.
Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006
Time frame: From enrollment to the end of treatment at 365 days after procedure
Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006, will be used. Classification where 0 means reflux greater than 1 second, 1 means reflux less than 1 second, and 2 means no reflux.
2 secondary outcomes
Treatment complications
Time frame: One to 365 after procedure
Pain Level During Procedure: Visual Analog Pain Scale
Time frame: Pain level during the procedure
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 1 May 2026.
- Background: PubMed 30098668Epstein D, Onida S, Bootun R, Ortega-Ortega M, Davies AH. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Health. 2018 Aug;21(8):911-920. doi: 10.1016/j.jval.2018.01.012. Epub 2018 Mar 15.
- Background: PubMed 35466820Petrone A, Peluso A, Ammollo RP, Turchino D, Del Guercio L, Andreucci M, Serra R, Bracale UM. Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience. Phlebology. 2022 Aug;37(7):522-528. doi: 10.1177/02683555221092194. Epub 2022 Apr 25.
- Background: PubMed 34378180Whing J, Nandhra S, Nesbitt C, Stansby G. Interventions for great saphenous vein incompetence. Cochrane Database Syst Rev. 2021 Aug 11;8(8):CD005624. doi: 10.1002/14651858.CD005624.pub4.
- Background: PubMed 18277340Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available.
- Individual participant dataSharing planned: Undecided. Undecided. Maybe after publication.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flebogrif and Polidocanol foam sclerotherapy in people with Varicose Veins of Leg With Long Saphenous Vein Distribution and Varicose Veins of Lower Limb, run by Antonio Eduardo Zerati 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 6 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Antonio Zerati, PhD (+5511996354925, a.zerati@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire (time frame: From enrollment to the end of treatment at 365 days after procedure). 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 NCT07561320, which also lists 4 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 1 May 2026.