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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07355959
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
3. Patient in maintenance phase of lymphedema treatment
4. Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
5. Signed informed consent prior to any study-mandated procedure.
Exclusion Criteria:
1. Active cellulitis / Infectious dermo-hypodermatitis
2. Lymphedema associated with active cancer needing acute chemotherapy
3. Motor and sensitive neurological deficiency / psychiatric or addictive disorders
4. Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
5. Pregnant or breastfeeding patient
6. Participation to any other clinical study which has an impact on the different endpoints
7. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07355959
Study Brief:
Protocol Section:
NCT07355959