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 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT01845935
Eligibility Criteria:
Inclusion Criteria:
* Patient over 18 years,
* Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI,
* Recurrence of symptoms after initial treatment,
* Symptomatic deformation :pain, tangible mass,functional discomfort
* Recurrence after treatment by surgery or sclerosis
* Cryotherapy considered technically feasible after discussion in multidisciplinary committee,
* Localization at distance from the skin and major neurovascular structures,
* Absence of contra-indication of anaesthesia,
* Signed informed consent,
* Coverage by French social security
Exclusion Criteria:
* Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve),
* TP \<50% TCA\> 1.5 x control, anticoagulation
* Platelets \<90000/mm3,
* Progressive infection
* Patient included in another clinical study,
* Unable to undergo medical tests for geographical, social or psychological,
* Adult under a legal guardianship or unable to consent,
* Pregnancy and breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01845935
Study Brief:
Protocol Section:
NCT01845935