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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT04203069
Eligibility Criteria:
Inclusion Criteria:
* Women responding positively to the lymphedema reduction phase defined by a ≥ 20% decrease in lymphedema volume at the end of DLT
* Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
* Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® Autofit armsleeve provided
* Signed informed consent prior to any study-mandated procedure
* Affiliated to the General regime of the Social Security or covered by a similar health insurance system
Non-inclusion criteria :
* Stage I lymphedema or located in several places
* Active cellulitis / Infectious dermo-hypodermatitis
* Lymphedema associated with active cancer needing acute chemotherapy
* Motor and sensitive neurological deficiency / psychiatric or addictive disorders
* Post-operative edema (i.e acute edema occurring during the days following breast cancer-related surgery)
* Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis, presence of skin lesions on the armsleeve placement
* Pregnant or breastfeeding patient
* Previous history of hypersensitivity to MOBIDERM® technology or lymphatrex garment General conditions
* Participation to any other clinical study which has an impact on the different endpoints
* Unlikely to be followed up to 3 months with clinical assessment as per investigator's judgment
* Vulnerable patient according to the article L.1121-6 of the French Public Health Code, the adults being the object of a legal protective measure or enable to express their consent according to the article L.1121-8 of French Public Health Code
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04203069
Study Brief:
Protocol Section:
NCT04203069