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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03304834
Eligibility Criteria:
Inclusion Criteria:
* Candidate for venous procedure involving lower limb superficial insufficiency, recurrence at the thigh/groin level or perforators incompetence.
* Physical condition allowing ambulation after the procedure.
* Availability of the patient for all the follow-up visits.
* Targeted tissue reachable for treatment with the device- meaning between 5mm and 26mm below the skin surface.
* Age over 18 years of age at the time of enrollment.
* No acute venous thrombosis.
* No complete, or near complete deep vein thrombosis.
* Patient has signed a written informed consent.
Exclusion Criteria:
* Patient is pregnant or nursing
* Known allergic reaction to anesthetics to be used
* Legally incapacitated or imprisoned patients
* Patient's vein target not clearly visible on the ultrasound images (in B mode) at the inclusion visit.
* Patient participating in another clinical trial involving an investigational drug, device or biologic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03304834
Study Brief:
Protocol Section:
NCT03304834