Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Launched by THUASNE · Feb 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of arm sleeve called the Auto-Adjustable MOBIDERM® Autofit Armsleeve. The goal of the study is to see how well this sleeve helps manage swelling in the arm (called lymphedema) that some women experience after breast cancer treatment. Researchers want to find out if this new sleeve is more effective than traditional compression bandages in reducing the size of the swollen arm.

To participate in this study, women aged 65 to 74 who have significant swelling in one arm, which is at least 10% larger than the other arm, may be eligible. Participants will need to fit into one of the standard sizes of the new armsleeve and must provide consent to take part in the study. If you join, you can expect to wear the armsleeve and possibly have your arm measurements taken over the course of the trial. It's important to note that certain conditions may exclude women from participating, such as having early-stage lymphedema or any medical issues that make compression therapy unsuitable.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.