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Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase

NCT04203069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-09-23

No results posted yet for this study

Summary

This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.

Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.

Conditions

  • Lymphedema of Upper Arm

Interventions

DEVICE

Control group : Day-time compression sleeve

In the control group, patients wear only day-time compression garment : lymphatrex during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).

DEVICE

Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit

In the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months. The protocol will require 3 visits during the maintenance phase. Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group). Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group) Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Thuasne

    lead INDUSTRY

Principal Investigators

  • ISABELLE QUERE, PUPH,MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-12-30
Completion
2024-09-15

Countries

  • France
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203069 on ClinicalTrials.gov