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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT05663359
Eligibility Criteria:
Inclusion Criteria:
* Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)
* Patient candidate for endothermic treatment of the lower limbs
* CEAP: C2 - C6
* Patient with a target vein diameter (GSV and/or SSV) \>= 3 mm throughout the target vein segment
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed the informed consent
Exclusion Criteria:
* Patient with a current serious pathology and/or a life expectancy of less than 5 years
* Patient who has had a deep or superficial vein thrombosis in the previous 6 months
* Obliterating arteriopathy of the lower limb concerned, with an IPS \< 0.8 or \> 1.3
* Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb
* Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb
* Suspicion of non-post-thrombotic iliac compression on echo-doppler
* Contraindication to the planned treatment technique
* Patient whose geographical distance is not compatible with the follow-up of the study
* Pregnant or breastfeeding women
* Patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires.
* Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05663359
Study Brief:
Protocol Section:
NCT05663359