Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
Launched by THUASNE · Sep 30, 2014
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
- • Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
- • Lymphoedema with evident pitting sign (assessed as ++ or +++)
- • Requiring compression therapy for, at least, the next 3 months.
- • Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
- • Signed informed consent prior to any study-mandated procedure.
- • Not under any administrative or legal supervision.
- • Covered by a health insurance system
- Exclusion Criteria:
- • Stage I lymphoedema
- • Active cellulitis
- • Lymphoedema associated with active cancer needing acute chemotherapy
- • Motor and sensitive neurological deficiency
- • Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
- • Patient participating in any other clinical study
- • Unlikely to be followed up to 3 months with clinical assessment
About Thuasne
Thuasne is a leading international medical device company specializing in the development, manufacturing, and distribution of orthopedic and rehabilitation solutions. With a commitment to innovation and quality, Thuasne aims to enhance patient outcomes through advanced technologies and tailored therapeutic approaches. The company focuses on creating products that support mobility, recovery, and pain relief, leveraging its expertise in biomechanics and material science. Thuasne's dedication to clinical research and collaboration with healthcare professionals ensures that its offerings are grounded in evidence-based practices, making it a trusted partner in the field of medical devices and rehabilitation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montpellier Cedex 5, , France
Patients applied
Trial Officials
Isabelle Quere, Prof
Principal Investigator
University Hospital, Montpellier
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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