Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02253186
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Thuasne

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphedema Device: Auto-Adjustable MOBIDERM Armsleeve Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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 Name: 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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253186


Locations
Layout table for location information
France
CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Montpellier Cedex 5, France, 34295
Sponsors and Collaborators
Thuasne
Investigators
Layout table for investigator information
Principal Investigator: Isabelle Quere, Prof University Hospital, Montpellier

Layout table for additonal information
Responsible Party: Thuasne
ClinicalTrials.gov Identifier: NCT02253186     History of Changes
Other Study ID Numbers: 2014-A01008-39
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases