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.
NCT07355959 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-01-29
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.
Conditions
- Limb Lymphoedema
Interventions
- DEVICE
-
MOBIDERM Autofit Armsleeve
The MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month.
- DEVICE
-
Self-bandages
Self-bandages will be worn by the patients at night for one month.
Sponsors & Collaborators
-
Thuasne
lead INDUSTRY
Principal Investigators
-
Christina Lindemann, Physician · Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-15
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- Germany
Study Locations
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