Not Yet RecruitingNot Applicable

Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.

Germany16 participantsStarted 2026-01-15

Plain-language summary

The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Age ≥ 18 years
✓. Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
✓. Patient in maintenance phase of lymphedema treatment
✓. Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
✓. Signed informed consent prior to any study-mandated procedure.

Exclusion criteria

✕. Active cellulitis / Infectious dermo-hypodermatitis
✕. Lymphedema associated with active cancer needing acute chemotherapy
✕. Motor and sensitive neurological deficiency / psychiatric or addictive disorders
✕. Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
✕. Pregnant or breastfeeding patient
✕. Participation to any other clinical study which has an impact on the different endpoints
✕. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.

What they're measuring

Volume excess variation

Timeframe: 2 months (Inclusion, first month and second month visit)

Trial details

NCT IDNCT07355959

SponsorThuasne

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Stéphanie Villet, Dr

+33647780429 stephanie.villet@thuasne.fr

View on ClinicalTrials.gov More Limb Lymphoedema trials