NCT04558957

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Balton Sp.zo.o. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Venous Insufficiency, CVI

Interventions

Type	Name	Description
DEVICE	FLEBOGRIF	The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.

Timeline

• Start date: 2019-08-08
• Primary completion: 2021-08-12
• Completion: 2023-04-28
• First posted: 2020-09-22
• Last updated: 2023-06-18

Locations

4 sites across 1 country: Poland