Limb LymphoedemaMOBISCANNCT07355959
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.
A study testing MOBIDERM Autofit Armsleeve and Self-bandages in people with Limb Lymphoedema, run by Thuasne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Limb Lymphoedema
- What is being tested?
- MOBIDERM Autofit Armsleeve and Self-bandages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Ödemzentrum Bad Berleburg Klinik
Bad Berleburg, 57319
Christina Lindemann, Physician, 02751 804251, christina.lindemann@lymphklinik.com
About this study
Official title: 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.
Read the 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
- Limb Lymphoedema
- Being tested
- MOBIDERM Autofit Armsleeve, Self-bandages
- Keywords
- Lymphedema of upper limb, Compression garments, Lymphedema management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBIDERM Autofit ArmsleeveDevice
The MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month.
Self-bandagesDevice
Self-bandages will be worn by the patients at night for one month.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | Other | Night-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase). Receives: 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). Receives: Device: MOBIDERM Autofit Armsleeve; Device: Self-bandages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months (Inclusion, first month and second month visit)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limb LymphoedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over, randomized, open label study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Lindemann, Physician, Principal investigator, Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355959
- Sponsor's protocol ID
- EC55_MOBISCAN
- Acronym
- MOBISCAN
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cancer Information Sytem. https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ (September 2023, date last accessed).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07355959
- Acronym / sponsor ID
- MOBISCAN / EC55_MOBISCAN
- Conditions
- Limb Lymphoedema
- Keywords
- Lymphedema of upper limb, Compression garments, Lymphedema management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over, randomized, open label study
| Arm | Type | Receives |
|---|---|---|
| Group 1: | Other | Device: MOBIDERM Autofit Armsleeve, Device: Self-bandagesNight-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase). |
| Group 2: | Other | Device: MOBIDERM Autofit Armsleeve, Device: Self-bandagesSelf-bandages at night for the 1st month (1st phase) then Night-time MOBIDERM Autofit for the 2nd month (2nd phase). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBIDERM Autofit ArmsleeveThe MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month. | Device | Group 1:, Group 2: |
| Self-bandagesSelf-bandages will be worn by the patients at night for one month. | Device | Group 1:, Group 2: |
Primary outcome
Volume excess variation
Time frame: 2 months (Inclusion, first month and second month visit)
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.
6 secondary outcomes
Evolution of affected upper limb volume:
Time frame: 2 months (Inclusion, first month and second month visit)
Device pressure:
Time frame: 2 months (Inclusion, first month and second month visit)
Evolution of hand lymphedema:
Time frame: 2 months (Inclusion, first month and second month visit)
Comfort / Ease of use / satisfaction:
Time frame: 2 month visit
Compliance:
Time frame: 2 months
Patient's safety
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- BackgroundCancer Information Sytem. https://www.wcrf.org/cancer-trends/worldwide-cancer-data/ (September 2023, date last accessed).
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Lindemann, Physician principal investigator
Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOBIDERM Autofit Armsleeve and Self-bandages in people with Limb Lymphoedema, run by Thuasne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Villet, Dr (+33647780429, stephanie.villet@thuasne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume excess variation (time frame: 2 months (Inclusion, first month and second month visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.