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 | Not Yet Recruiting

• 1 other identifier: EC55_MOBISCAN
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lymphedema of upper limb; Compression garments; Lymphedema management

Outcome Measures

Primary Outcomes (1)

• Volume excess variation

  The primary endpoint of this study is to compare the volume excess variation of the upper limb between both conditions: MOBIDERM Autofit and self-bandages after one month of treatment, using the SCANECA 3D scanner.

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

Secondary Outcomes (6)

• Evolution of affected upper limb volume:

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

• Device pressure:

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

• Evolution of hand lymphedema:

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

• Comfort / Ease of use / satisfaction:

  2 month visit

• Compliance:

  2 months

Study Arms (2)

Group 1:

OTHER

Night-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase).

Device: MOBIDERM Autofit Armsleeve; Device: Self-bandages

Group 2:

OTHER

Self-bandages at night for the 1st month (1st phase) then Night-time MOBIDERM Autofit for the 2nd month (2nd phase).

Device: MOBIDERM Autofit Armsleeve; Device: Self-bandages

Interventions

MOBIDERM Autofit Armsleeve DEVICE

The MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month.

Group 1:; Group 2:

Self-bandages DEVICE

Self-bandages will be worn by the patients at night for one month.

Group 1:; Group 2:

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

Ödemzentrum Bad Berleburg Klinik

Bad Berleburg, 57319, Germany

Location

Related Publications (1)

• Cancer Information Sytem. https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ (September 2023, date last accessed).

  BACKGROUND

Study Officials

• Christina Lindemann, Physician

  Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Villet, Dr

CONTACT

+33647780429; stephanie.villet@thuasne.fr

Alyssia Marques

CONTACT

+33 6 48 22 64 56; alyssia.marques@thuasne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cross-over, randomized, open label study

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)