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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT06711120
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years and ≤90 years;
* Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
* Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
* Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
* Only one limb per patient was selected for inclusion in the study;
* Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.
Exclusion Criteria:
* Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
* Recurrent varicose veins after previous treatment.
* Severe distortion of the great saphenous vein with anticipated catheter failure.
* Severe lower limb ischaemia (CLI) (ABPI \<0.8).
* Known allergy to medications and device materials involved in the study.
* Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
* Women who are pregnant or breastfeeding.
* Unable or unwilling to complete the questionnaire.
* Participating in a study of another drug or device.
* Life expectancy \<1 year.
* Those undergoing treatment for skin malignancies other than non-melanoma.
* Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
* In the judgement of the investigator, endovenous therapy is not appropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06711120
Study Brief:
Protocol Section:
NCT06711120