Clinical trial · Interventional
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.
Cross-over, Randomized, Open Label 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.
NCT07355959CI-TRIAL-00101902MOBISCANnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limb Lymphoedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOBIDERM Autofit Armsleeve | Device | — | UNRESOLVED |
| Self-bandages | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1:
- description
- Night-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase).
- interventionNames
- Device: MOBIDERM Autofit Armsleeve
- Device: Self-bandages
- type
- OTHER
- label
- Group 2:
- description
- Self-bandages at night for the 1st month (1st phase) then Night-time MOBIDERM Autofit for the 2nd month (2nd phase).
- interventionNames
- Device: MOBIDERM Autofit Armsleeve
- Device: Self-bandages
Primary outcomes (1)
- measure
- Volume excess variation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCancer Information Sytem. https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ (September 2023, date last accessed).