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. (MOBISCAN)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Limb Lymphoedema
• Intervention / Treatment: Device: MOBIDERM Autofit Armsleeve; Device: Self-bandages

Detailed Description

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology, named MOBIDERM Autofit.

The device has already been evaluated in several clinical studies as an adjuvant treatment to daily compressive garment during night-time maintenance phase in women with Breast cancer related lymphedema.

The possibility to use this category of devices during both phases of lymphedema treatment has been reinforced recently by studies that showed a similar reduction in lymphedema volume with wraps versus conventional multilayer bandages [Ochalek et al., 2023,Borman et al., 2021].

The global objective of the MOBISCAN study is to reinforce the efficacy of MOBIDERM Autofit garment by assessing its efficacy and pressure maintenance versus bandages in the management of upper limb Lymphedema in night-time maintenance phase.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssia Marques; Phone Number: +33 6 48 22 64 56; Email: alyssia.marques@thuasne.fr
• Study Contact Backup: Name: Stéphanie Villet, Dr; Phone Number: +33647780429; Email: stephanie.villet@thuasne.fr

Study Locations

• Germany
  • Bad Berleburg, Germany, 57319
    • Ödemzentrum Bad Berleburg Klinik
    • Contact: Christina Lindemann, Physician; Phone Number: 02751 804251; Email: christina.lindemann@lymphklinik.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: 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; 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.
Other: Group 2: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of affected upper limb volume:	Evolution of affected upper limb volume between baseline and 1 month of treatment with MOBIDERM Autofit and self-bandages in patients with upper limb lymphedema.	2 months (Inclusion, first month and second month visit)
Device pressure:	The level of pressure under the devices will be measured with Picopress during the 3 patient visits for each patient.	2 months (Inclusion, first month and second month visit)
Evolution of hand lymphedema:	The volume of the hand related to healthy and to affected upper limb will be measured at baseline and the volume of the hand related to affected upper limb after one month of treatment with MOBIDERM Autofit and bandages with a digital measure device and/or tape measurement to check and compare the absence of migration of lymphedema towards the hand between both conditions.	2 months (Inclusion, first month and second month visit)
Comfort / Ease of use / satisfaction:	A self-questionnaire will be completed by the patient at the end of the study when the patient tested each of the devices and is able to compare comfort, ease of use and satisfaction. A qualitative follow-up interview will be proposed to a dozen of patients at the end of the study to obtain their feed-back about their study treatments (overall experience, benefits of self-management, experience when putting on, taking off and adjusting the device).	2 month visit
Compliance:	The patient will complete a diary during the study to report the compliance with each device at night (Wear/not wear, number of hours).	2 months
Patient's safety	The Number and type of serious and non-serious Adverse Device Effects (ADE) with a focus on the cutaneous ADE will be collected during the study.	2 months

Collaborators and Investigators

• Sponsor: Thuasne
• Investigators: Principal Investigator: Christina Lindemann, Physician, Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Compression garments; Lymphedema of upper limb; Lymphedema management
• Other Study ID Numbers: EC55_MOBISCAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No