Trials / Not Yet Recruiting
Not Yet RecruitingNCT07355959
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.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Thuasne · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-01-15
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2026-01-21
- Last updated
- 2026-01-29
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT07355959. Inclusion in this directory is not an endorsement.