Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema

The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-Adjustable MOBIDERM Armsleeve

Device

Other names: MOBIDERM Autofit

Primary outcomes

Change in excess arm volume

Time frame: between Day 0 and Day 30

Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula

Sponsors and collaborators

Lead sponsor

Thuasne

Industry

Registry information

Official study title

Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase

Acronym: MARILYN

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 1, 2014
Registry last updated: Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed