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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04558957
Other study ID # POLFLEB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2019
Est. completion date April 28, 2023

Study information

Verified date June 2023
Source Balton Sp.zo.o.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 28, 2023
Est. primary completion date August 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Study inclusion criteria: 1. Signing the Informed Consent Form by the patient found eligible for the treatment with the mechanochemical method 2. The patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol 3. A patient with diagnosed varicose veins and diagnosed great saphenous vein (GSV) insufficiency confirmed by ultrasound (CEAP class C2-C6) 4. Favourable anatomy enabling the introduction of the Flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below SFJ) 5. Diameter of the treated vein of 4-10 mm 6. No data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records 7. No clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a Doppler ultrasound examination 8. No medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses 9. No cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method 10. No clinical data indicating recent thrombosis within the deep vein system 11. No clinical data on diabetes with vascular complications 12. No clinical data indicating an active neoplastic process Study exclusion criteria: 1. Recent deep vein thrombosis or occlusion 2. Congenital disorders with associated occlusion of deep system veins 3. Pregnancy and breast-feeding 4. Lower limb ischaemia 5. Severe lymphatic oedema 6. Bleeding diatheses 7. Documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation 8. Purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation 9. Previous procedures on insufficiency veins of the superficial system 10. Acute infection 11. History of great saphenous vein thrombosis 12. End-stage kidney disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FLEBOGRIF
The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.

Locations

Country Name City State
Poland Centrum Chirurgii i Stomatologii Jaworuccy Sp. P. Gorzów Wielkopolski
Poland Centrum Medyczne Angelius Provita; Europejskie Centrum Flebologii Katowice
Poland Medyczne Centrum Naleczów sp. z o.o. Lublin
Poland Klinika Dorobisz Wroclaw

Sponsors (2)

Lead Sponsor Collaborator
Balton Sp.zo.o. KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Occlusion rate Occlusion rate of the great saphenous vein at 1, 6, 12, 18 and 24 months 1, 6, 12, 18, 24 months
Secondary 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 1, 3, 6, 12, 18, 24 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Period needed to resume normal activities Period needed to resume normal activities up to 2 years after the treatment
Secondary 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
Secondary Complications rate Complications rate including deep vein thrombosis, nerve damage, infections, etc. up to 2 years after the treatment