Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
Chronic Venous Insufficiency, CVI Clinical Trial
Official title: 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
Clinical Trial 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.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.