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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2019-A02043-54 |
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| Name | Class |
|---|---|
| University Hospital, Tours | OTHER |
| Delta Consultants | UNKNOWN |
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MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated.
The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobiderm | Experimental | MOBIDERM® autofit : auto-adjustable compression stocking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOBIDERM® autofit : auto-adjustable compression stocking | Device | The experimental protocol will require 2 visits during usual reduction phase performed at the hospital (5 days of hospitalization). Visit 1 will be performed the first day of hospitalization and will consist of inclusion visit and some evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics). Between visit 1 (D1) and visit 2 (D3), patients will wear Mobiderm Autofit continually. Visit 2 will be performed the third day of hospitalization and will consist of evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics, satisfaction survey). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline extraction rates at 3 days after wearing MOBIDERM | Assess the difference of extraction rate (%) in different areas (ankle, upper and lower middle third of the leg, knee, calf) by lymphoscintigraphy performed at D1 and D3 after wearing MOBIDERM® | Day : 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of vascular lymphatic activity between D1 and D3 | Assess change of vascular lymphatic activity based on qualitative data (activity YES/NO ; quality of activity : usual - semi usual - unusual) obtained during dynamic acquisition of lymphoscintigraphy from baseline to D3 | Day : 3 |
| Change of lymphatic vascular flow between D1 and D3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loïc VAILLANT, MD | University Hospital of Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Tours | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28281052 | Background | Mestre 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. | |
| 24931830 |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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non-randomized, open-labelled, monocentric study
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Assess change of amplitude vascular flow : important - medium- weak ; and of flow velocity : normal, slow, inexistent from baseline to D3 |
| Day : 3 |
| Change on lymphatic system between D1 and D3 : short term effect | Assess change on lymphatic system from baseline to D3 (short term effect) , based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO. | Day : 3 |
| Change on lymphatic system between H2 and H4 : immediate effect | Assess change on lymphatic system from baseline to 2 and 4 hours : immediate effect, based on quantitative data : number of lympho node fixation ; and qualitative data: lympho node fixation intensity : important - medium - low ; tortuous appearance of the lymphatic vessels : YES/NO ; presence of collateral : YES/NO ; presence of dermal reflux : YES/NO ; presence of popliteal ganglion : YES/NO. | Hours : 2 and 4 |
| Lymphedema volume reduction between D1 and D3 | Leg perimeters (cm) of 7 part of leg will be measured (ankle, patella, +10cm +20cm +30cm and -10cm -20cm and -30cm of patella). Based on truncated cone formula, volume (mL) of each leg will be calculated. These volumes will be compared between D1 and D3 in order to assess lymphedema volume reduction. | Days : 1 and 3 |
| Skin condition evolution between D1 and D3 | Skin condition will be assessed by cutaneous ultrasound scan (skin thickness (mm) , skin echogenicity (hypoechogenicity - isoechogenicity, hyperechogenicity) , oedema distribution in the dermis (superficial dermis - deep dermis - overall of dermis -hypodermis and dermis) performed on 3 areas : ankle, leg and thigh. Skin condition evolution will be assessed at D1 and D3. | Days : 1 and 3 |
| Cutaneous suppleness between D1 and D3 | Cutaneous suppleness evolution is assessed with a cutometer. Cutaneous suppleness is described by skin elasticity, elastic capacity and viscoelasticity. Cutometer measurements are expressed in millimetre (skin deformation, skin relaxation, skin extensibility) and will be presented as quantitative data. | Days : 1 and 3 |
| Number of type of serious and non-serious Adverse Device Effects | Number and type of serious and non-serious Adverse Device Effects (ADE) will be reported during the study | Day : 3 |
| Satisfaction regarding MOBIDERM | Satisfaction is measured by a satisfaction questionnaire wrote specifically for the study. This questionnaire is focused on positioning the product, comfort, esthetic and global satisfaction. | Day : 3 |
| Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |