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

Lymphedema Clinical Trial

— MARILYN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253186
• Other study ID #: 2014-A01008-39
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: December 4, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Auto-Adjustable MOBIDERM Armsleeve

Locations

Country	Name	City	State
France	CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires	Montpellier Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in excess arm volume	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	between Day 0 and Day 30	No