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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Venous Insufficiency, CVI
- Sponsor
- Balton Sp.zo.o.
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- Primary efficacy endpoint: Occlusion rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary efficacy endpoint: Occlusion rate
Time Frame: 3 months
Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months
Primary safety endpoint: Rate of SAE
Time Frame: 30 days after the procedure
Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure
Secondary Outcomes
- Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale(0-7 days after procedure)
- Period needed to resume normal activities(up to 2 years after the treatment)
- Number of Participants with no reflux in treated segment of the vein(1, 3, 6, 12, 18, 24 months)
- Period needed to return to work (sick leave period)(up to 2 years after the treatment)
- Clinical success - changes in rVCSS(12 and 24 months)
- Complications rate(up to 2 years after the treatment)
- Occlusion rate(1, 6, 12, 18, 24 months)
- Change in quality of life by Aberdeen Varicose Vein Questionnaire(12 and 24 months)
- Assessment of pain during the procedure(During procedure)
- Assessment of the need for analgesic treatment(0-7 days after procedure)