Clinical Study to Assess the Safety and Efficacy of Mechanochemical Ablation With Flebogrif in Patients With Great Saphenous Vein Insufficiency
- Conditions
- Chronic Venous Insufficiency, CVI
- Interventions
- Device: FLEBOGRIF
- Registration Number
- NCT04558957
- Lead Sponsor
- Balton Sp.zo.o.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FLEBOGRIF FLEBOGRIF Interventions will be performed using Flebogrif catheter.
- Primary Outcome Measures
Name Time Method Primary efficacy endpoint: Occlusion rate 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 30 days after the procedure Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure
- Secondary Outcome Measures
Name Time Method Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale 0-7 days after procedure Assessment of pain within 0-7 days after the procedure (VAPS 0-10, daily assessment). Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain).
Period needed to resume normal activities up to 2 years after the treatment Period needed to resume normal activities
Number of Participants with no reflux in treated segment of the vein 1, 3, 6, 12, 18, 24 months Number of Participants with no reflux in the treated segment of the great saphenous vein at 1, 3, 6, 12, 18 and 24 months
Clinical success - changes in rVCSS 12 and 24 months Clinical success, defined as change in rVCSS classification (Revised Venous Clinical Severity Score) after 12 and 24 months
Scale score 0-30; higher score = worse outcome.Period needed to return to work (sick leave period) up to 2 years after the treatment Period needed to return to work (sick leave period)
Complications rate up to 2 years after the treatment Complications rate including deep vein thrombosis, nerve damage, infections, etc.
Occlusion rate 1, 6, 12, 18, 24 months Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months
Change in quality of life by Aberdeen Varicose Vein Questionnaire 12 and 24 months Change in quality of life measured with the use of the Aberdeen Varicose Vein Questionnaire at 12 and 24 months
Scale score: 0-100; higher score = worse outcome.Assessment of pain during the procedure During procedure Assessment of pain during the procedure (Visual Analogue Pain Scale, VAPS) ranging from 0 to 10. Pain assessed using the Visual Analogue Scale (range 0-10; 0 = no pain; 2 = mild pain, 4 = nagging, annoying pain; 6 = severe pain; 8 = very severe pain; 10 = unbearable pain).
Assessment of the need for analgesic treatment 0-7 days after procedure Assessment of the need for analgesic treatment after the procedure (0-7 days)
Trial Locations
- Locations (4)
Centrum Chirurgii i Stomatologii Jaworuccy Sp. P.
🇵🇱Gorzów Wielkopolski, Poland
Medyczne Centrum Nałęczów sp. z o.o.
🇵🇱Lublin, Poland
Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii
🇵🇱Katowice, Poland
Klinika Dorobisz
🇵🇱Wrocław, Poland