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| Name | Class |
|---|---|
| KCRI | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLEBOGRIF | Experimental | Interventions will be performed using Flebogrif catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLEBOGRIF | Device | The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: Occlusion rate | Primary efficacy endpoint: Occlusion rate of the great saphenous vein in the treated segment at 3 months | 3 months |
| Primary safety endpoint: Rate of SAE | Primary safety endpoint: Rate of serious adverse events within 30 days after the procedure | 30 days after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion rate | Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months | 1, 6, 12, 18, 24 months |
| Number of Participants with no reflux in treated segment of the vein | Number of Participants with no reflux in the treated segment of the great saphenous vein at 1, 3, 6, 12, 18 and 24 months |
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Study inclusion criteria:
Study exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum Chirurgii i Stomatologii Jaworuccy Sp. P. | Gorzów Wielkopolski | 66-400 | Poland | |||
| Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii |
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| 1, 3, 6, 12, 18, 24 months |
| Change in quality of life by Aberdeen Varicose Vein Questionnaire | 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. | 12 and 24 months |
| Clinical success - changes in rVCSS | 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. | 12 and 24 months |
| Assessment of pain during the 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). | During procedure |
| Assessment of pain within 0-7 days after the procedure: Visual Analogue Scale | 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). | 0-7 days after procedure |
| Assessment of the need for analgesic treatment | Assessment of the need for analgesic treatment after the procedure (0-7 days) | 0-7 days after procedure |
| Period needed to resume normal activities | Period needed to resume normal activities | up to 2 years after the treatment |
| Period needed to return to work (sick leave period) | Period needed to return to work (sick leave period) | up to 2 years after the treatment |
| Complications rate | Complications rate including deep vein thrombosis, nerve damage, infections, etc. | up to 2 years after the treatment |
| Katowice |
| 40-611 |
| Poland |
| Medyczne Centrum Nałęczów sp. z o.o. | Lublin | 20-950 | Poland |
| Klinika Dorobisz | Wroclaw | 54-130 | Poland |
| ID | Term |
|---|---|
| D019575 | Blindness, Cortical |
| ID | Term |
|---|---|
| D001766 | Blindness |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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