Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
Recruiting now · Not applicable
Conditions studied: Lymphedema of Upper Limb
In brief
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
Key facts
- Study ID
- NCT06264817
- Run by
- Thuasne
- People needed
- 40
- Starts
- 2024-03-15
- Expected to finish
- 2025-04-15
- Last updated by the study team
- 2024-09-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- ANKARA — Ankara, Turkey (Türkiye) (enrolling)
- Pinar BORMAN — Ankara, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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