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Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency | Clinical Trials | Clareo Health

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Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency

Prospective, Multi-centre Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With the Use of Flebogrif in Patients With Great Saphenous Vein Insufficiency

NCT04558957•Balton Sp.zo.o.

View on ClinicalTrials.gov

Summary

The objective of the study is to collect clinical data of patients in whom Flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of Flebogrif®. The proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of Flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method
•2. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol
•3. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6)
•4. Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ)
•5. Diameter of the treated vein of 4-10 mm
•6. No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records
•7. No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination
•8. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses
•9. No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method
•10. No clinical data indicating recent thrombosis within the deep vein system
+2 more criteria

Exclusion Criteria

•1. Recent deep vein thrombosis or occlusion
•2. Congenital disorders with associated occlusion of deep system veins
•3. Pregnancy and breast-feeding
•4. Lower limb ischaemia
•5. Severe lymphatic oedema
•6. Bleeding diatheses
•7. Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation
•8. Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation
•9. Previous procedures on insufficiency veins of the superficial system
•10. Acute infection
+2 more criteria

Locations (4)

Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.

Gorzów Wielkopolski, Poland

Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii

Katowice, Poland

Medyczne Centrum Nałęczów sp. z o.o.

Lublin, Poland

Klinika Dorobisz

Wroclaw, Poland

Key Dates

Start Date

August 8, 2019

Primary Completion Date

August 12, 2021

Completion Date

April 28, 2023

Last Updated

June 18, 2023

Enrollment

200

ACTUAL participants

Conditions

Chronic Venous Insufficiency, CVI

Interventions

FLEBOGRIF

DEVICE

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Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency

Inclusion Criteria

Exclusion Criteria

Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over

Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

Respiratory Functions, Aerobic Capacity and Quality of Life in Chronic Venous Insufficiency