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

December 4, 2015 updated by: Thuasne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier Cedex 5, France, 34295
        • CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I
Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
Device: Auto-Adjustable MOBIDERM Armsleeve
Other Names:
  • MOBIDERM Autofit
NO_INTERVENTION: Group II
Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between Day 0 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thuasne

Investigators

  • Principal Investigator: Isabelle Quere, Prof, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (ESTIMATE)

October 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01008-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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