Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT04558957
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04558957
Study Brief:
Protocol Section:
NCT04558957