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:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT02345018
Eligibility Criteria:
Inclusion Criteria:
1. Symptomatic varicose veins, C2-C5
2. Ultrasound criteria:
1. Diameter supragenual great saphenous vein (GSV) \>/= 12 mm , not tortuous; or
2. Insufficient antero-lateral branch; or
3. Insufficient below knee GSV
3. Signed informed consent
4. Patient consents to follow-up
5. Age \> 18 year en \< 80 year
Exclusion Criteria:
1. Patient is not capable to provide informed consent
2. Pregnancy and lactation
3. C6 varicose veins
4. Previous surgery or endovenous ablation at to treated segment
5. Deep venous vein thrombosis in medical history
6. Oral anti-coagulant therapy
7. Contra-indications or allergy for sclerosant
8. Immobilisation
9. Coagulant disorders or increased risk for thrombo-embolic complications: known coagulant disorders such as hemophilia A, hemophilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history
10. Fontaine III of IV peripheral arterial disease
11. Severe kidney disease: known GFR \< 30 ml/min
12. Liver diseases accompanied by changes in coagulation of the blood, anamnestic indications for tendency towards haemorrhage , such as epistaxis and spontaneous hematoma, known liver cirrhosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02345018
Study Brief:
Protocol Section:
NCT02345018