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)

THUASNE

Status: Not yet enrolling

Conditions: Limb Lymphoedema

Treatments: Device: MOBIDERM Autofit Armsleeve; Device: Self-bandages

Study type: Interventional

Funder types: Industry

Identifiers

NCT07355959

EC55_MOBISCAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1:

Other group

Description:

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

Treatment:

Device: Self-bandages

Device: MOBIDERM Autofit Armsleeve

Group 2:

Other group

Description:

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

Treatment:

Device: Self-bandages

Device: MOBIDERM Autofit Armsleeve