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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT04602559
Eligibility Criteria:
Inclusion Criteria:
* Primary or secondary pelvic or genital lymphedema of stage II ou III according to the criteria defined by the International Society of Lymphology.
* Patient with discomfort related to lymphedema
* Presence of the Stemmer's sign if applicable
* Patient with a morphology compatible with the 6 sizes of the MOBIDERM Panty (Minimum and maximum pelvic circumference: 88 and 129 cm respectively)
* Patient who gave signed, informed, voluntary consent prior to any intervention in the study
* Patient affiliated to the General regime of the Social Security or covered by a similar health insurance system
Exclusion Criteria:
* Pregnant woman or woman of childbearing age without contraception
* Patient with surgery of the small pelvis or genitals performed within the last 3 months prior to inclusion or any surgery scheduled during the study period
* Patient with hydrocoele
* Patient who had intensive reduction therapy for lower limb lymphedema within the last month
* Patient with a contraindication to compression, such as untreated infection, skin irritation, recent thrombosis (\< 3 months), obliterative arterial disease of the lower limbs with a systolic pressure index \< 0.6, phlegmatia coerulea dolens (painful blue phlebitis with arterial compression) in the thigh area
* Patient with decompensated heart failure
* Patient with a known allergy to the components used in the Panty
* Patient with untreated or escaped cancer
* Patient with a postectomy within the last 3 months prior to inclusion
* Patient with significant edema localized only to the labia minora
* Patient with psychiatric, psychological or neurological disorders that are incompatible with proper follow-up of a clinical study
* Patient participating in other research involving the human person impacting the main judgement criteria
* Patient cannot be followed for 12 weeks
* Vulnerable patient according to article L1121-6 of the French public health code, or subject being the object of a legal protective measure or enable to express his consent freely
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04602559
Study Brief:
Protocol Section:
NCT04602559