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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT01368159
Eligibility Criteria:
Inclusion Criteria:
General:
* Patient at least 18 years old
* Patient agreeing to give her informed consent in writing
* Patient taking effective contraceptive on inclusion and not planning pregnancy during the trial period.
* Patient registered with the social security or equivalent regime;
Linked to the pathology:
* Patient suffering from truncal insufficiency of the SVG supplied either by reflux from the saphenofemoral junction, with or without competent terminal valve, or by collaterals or perineal varicosities in the subinguinal region and who is scheduled to have endovenous injection of sclerotherapeutic foam into the great saphenous vein presenting truncal reflux of at least one second, the diameter of which is at least 4 mm (no limit for maximum calibre) standing 15 cm from the inguinal fold (according to an echo-doppler taken less than three months prior to inclusion).
* Injection initially planned of 2% Aetoxisclerol, the injection volume of which is limited to 3 ml of liquid, i.e. less than 15 ml of foam, for complete filling of the great saphenous and a spasm. (to standardise the procedure before fitting the compression hose) Patient classified C2 to C5 (clinical stages in CEAP classification).
Exclusion Criteria:
* General:
* Patient regularly taking analgesics or anti-inflammatories.
* Patient suffering from a state or prior history of mental or psychiatric disorder or any other factor limiting aptitude to take an informed part and respect of the protocol; Patient suffering from chronic hepatopathology.
* Renal insufficiency (clearance \< 60 ml/min. according to Cockcroft).
* Patient suffering from a known evolving malignant pathology.
* Patient suffering from decompensated cardiac or respiratory insufficiency.
* Patient who is pregnant or breast-feeding.
* Patient currently taking part in a clinical trial or who took part in a clinical trial during the month preceding inclusion.
* Person deprived of liberty by a legal or administrative decision, Adult patient protected by the law, under legal protection or guardianship.
Linked to the pathology/product:
* Patient suffering from LL pain other than vascular (sciatica, gonarthrosis, neuropathy, etc.)
* Patient presenting contraindications for class III venous compression (20 to 36 mmHg)
* Patient with a prior history of skin reactions following the use of venous compression products
* Scheduling a procedure for endovenous injection other than into the great saphenous vein during the period of study of the leg, planned during the 2 months following SVG sclerosis.
* Patient displaying post-thrombotic or primary anomalies of the deep vein network on the Echo-Doppler (less than 3 months before inclusion).
* Patient suffering from arteriopathy of the lower limbs with a systolic pressure index at the ankle of \< 0.6
* Saphenous incompetence not meeting the anatomical and/or haemodynamic criteria defined in the inclusion criteria.
* Open ulcer in the LL (C6 of CEAP classification).
* Patient not tolerating compression or requiring chronic fitting of high pressure compression (in excess of 20 mmHg).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01368159
Study Brief:
Protocol Section:
NCT01368159