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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT07125092
Eligibility Criteria:
Inclusion Criteria:
* Lipedema diagnosed at least in the legs according to the initial Wold criteria modified by Herbst.
* Average pain in the legs over the last week ≥ 4 points on a 10 points Numerical Rating Scale visual analogue scale.
* Patient who has given his informed consent freely and signed it prior to any intervention in the study.
Exclusion Criteria:
* Patient for whom compression is contraindicated, such as untreated infections, skin irritation or lesions.
* Lipedema type I: Hips/buttocks.
* Patients who underwent liposuction.
* Patient with a WHtR higher than 0,58.
* Patient with active cancer, chemotherapy treatment, chronic inflammatory disease, chronic anti-inflammatory therapy (ex: TNF alpha).
* Patient with surgery scheduled/planned during the study period.
* Patient with a known allergy to the components used in the devices.
* Pregnant woman or woman of childbearing age without contraception.
* Patient currently participating in another clinical investigation that could impact the study endpoints.
* Patient with psychiatric, psychological, or neurological disorders that are incompatible with the proper follow-up of the clinical investigation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07125092
Study Brief:
Protocol Section:
NCT07125092