Lymphedema of Upper LimbLyberTNCT06264817
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
A study testing MOBIDERM Autofit Armsleeve and Compressive bandaging in people with Lymphedema of Upper Limb, run by Thuasne at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- MOBIDERM Autofit Armsleeve and Compressive bandaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Volume difference between affected and healthy arm ≥ 10%
- Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
- Signed informed consent prior to any study-mandated procedure.
Who cannot join
- Stage I lymphedema or located in several places.
- Patients for whom compression is contraindicated.
- Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- Pregnant or breastfeeding patient
- Patient intolerant to MOBIDERM Autofit or known allergies to the components used.
- 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
2 sites in 1 country.
About this study
Official title: A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
Read the detailed description
The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.
The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.
In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- MOBIDERM Autofit Armsleeve, Compressive bandaging
- 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
In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks.
During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks
Compressive bandagingDevice
In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks.
During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group : compressive bandaging | Active comparator | Control group : compressive bandaging:
* Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice
* Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night Receives: Device: Compressive bandaging |
| Intervention group: MOBIDERM Autofit Armsleeve | Experimental | Intervention group: MOBIDERM Autofit Armsleeve
* Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time)
* Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night Receives: Device: MOBIDERM Autofit Armsleeve |
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 between both groups the volume evolution of the upper limb between inclusion and the end of the study. Limb Volume is calculated with truncated cone formula.
Measured: 8 weeks
Secondary outcomes (12)
Resource consumption
Resource consumption is measured by time of transports (travel time in minutes).
Measured: 3 and 8 weeks
Resource consumption
Resource consumption is measured by number of used medical devices (number).
Measured: 3 and 8 weeks
Resource consumption
Resource consumption is measured by the number and duration (per minute) of lymphedema-related healthcare consultations and hospitalizations.
Measured: 3 and 8 weeks
Lymphedema related Quality of life (QoL)
The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool is designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain is scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit
Measured: 3 and 8 weeks
Doctors' opinion on improving the patient's health condition
Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I questionnaire (Clinical Global Improvement Impression). This questionnaire allows doctors to evaluate the improvement of patients. The scale has 7 levels from "very strongly improved"(better outcome) to "very strongly aggravated"(worse outcome).Intermediate levels are: " Significantly improved " ; " Slightly improved " ; " No improvement " ; " Slightly aggravated " ; " Seriously aggravated "
Measured: 3 and 8 weeks
Patient's opinion on Global Impression of Change
Patient's opinion on Global Impression of Change about her general condition is measured by the PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Measured: 3 and 8 weeks
Satisfaction about the device
Patient's satisfaction with regards to MOBIDERM® Autofit vs bandages is measured by a satisfaction questionnaire. This questionnaire is focused on the product positioning with a question with 4 levels: very easy (better outcome), easy, difficult, very difficult (worse outcome) and the comfort with a question with 4 levels very comfortable (better outcome), comfortable, uncomfortable, very uncomfortable (worse outcome).
Measured: 8 weeks
The safety
Number and type of serious and non-serious Adverse Device Effects (ADE).
Measured: 8 weeks
Compliance to treatment
The compliance to treatment (day-time and night-time) is reported by the physician in the e-CRF according to the patient diary. The compliance is measured in number of days and or nights when the device is worn and the average wearing time
Measured: 8 weeks
General quality of life (QoL)
The evolution of QoL is measured by the EQ5D3L questionnaire completed by the patient. The EQ-5D3L questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems (Level 1 is coded as a '1'), moderate problems (Level 2 is coded as a '2'), and extreme problems (Level 3 is coded as a '3'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.
Measured: 3 and 8 weeks
Skin elasticity
The evolution of skin thickness and elasticity is measured by ultrasound
Measured: 3 and 8 weeks
Ttissue induration
The evolution of tissue induration is measured via the skinfibrometer (Delfin Tech).
Measured: 3 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Mar 2024
- Primary completion27 Jun 2025
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper LimbStudies 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
- Parallel groups
- Model description
- Prospective, multi-center, interventional, controlled-randomized, single blinded study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burcu DUYUR ÇAKIT, Principal investigator, Ankara Training and Research Hospital Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264817
- Sponsor's protocol ID
- EC 48 LyberT
- Acronym
- LyberT
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.
PubMed 37106735Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.
PubMed 28281052Borman P, Koyuncu EG, Yaman A, Calp E, Koc F, Sargut R, Karahan S. The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2021 Jun;19(3):286-294. doi: 10.1089/lrb.2020.0088. Epub 2020 Dec 2.
PubMed 33270499
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)
- ClinicalTrials.gov ID
- NCT06264817
- Acronym / sponsor ID
- LyberT / EC 48 LyberT
- Conditions
- Lymphedema of Upper Limb
- Keywords
- Lymphedema of upper limb, Compression garments, lymphedema management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 20 Feb 2024 (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.
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
Detailed description
The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages.
The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan.
In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, interventional, controlled-randomized, single blinded study
| Arm | Type | Receives |
|---|---|---|
| Control group : compressive bandaging | Active comparator | Device: Compressive bandagingControl group : compressive bandaging: * Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice * Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night |
| Intervention group: MOBIDERM Autofit Armsleeve | Experimental | Device: MOBIDERM Autofit ArmsleeveIntervention group: MOBIDERM Autofit Armsleeve * Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time) * Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Volume difference between affected and healthy arm ≥ 10%
- Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
- Signed informed consent prior to any study-mandated procedure.
Key exclusion criteria (8 listed)
- Stage I lymphedema or located in several places.
- Patients for whom compression is contraindicated.
- Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- 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 ArmsleeveIn the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks | Device | Intervention group: MOBIDERM Autofit Armsleeve |
| Compressive bandagingIn the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks | Device | Control group : compressive bandaging |
Primary outcome
Volume excess variation
Time frame: 8 weeks
The primary endpoint of this study is to compare between both groups the volume evolution of the upper limb between inclusion and the end of the study. Limb Volume is calculated with truncated cone formula.
12 secondary outcomes
Resource consumption
Time frame: 3 and 8 weeks
Resource consumption
Time frame: 3 and 8 weeks
Resource consumption
Time frame: 3 and 8 weeks
Lymphedema related Quality of life (QoL)
Time frame: 3 and 8 weeks
Doctors' opinion on improving the patient's health condition
Time frame: 3 and 8 weeks
Patient's opinion on Global Impression of Change
Time frame: 3 and 8 weeks
Satisfaction about the device
Time frame: 8 weeks
The safety
Time frame: 8 weeks
Compliance to treatment
Time frame: 8 weeks
General quality of life (QoL)
Time frame: 3 and 8 weeks
Skin elasticity
Time frame: 3 and 8 weeks
Ttissue induration
Time frame: 3 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 37106735Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.
- Background: PubMed 28281052Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.
- Background: PubMed 33270499Borman P, Koyuncu EG, Yaman A, Calp E, Koc F, Sargut R, Karahan S. The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2021 Jun;19(3):286-294. doi: 10.1089/lrb.2020.0088. Epub 2020 Dec 2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Burcu DUYUR ÇAKIT principal investigator
Ankara Training and Research Hospital Turkey
2 sites 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 Compressive bandaging in people with Lymphedema of Upper Limb, run by Thuasne at 2 sites in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume excess variation (time frame: 8 weeks). 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 NCT06264817, which also lists 3 linked publications.
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 14 Oct 2026.