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

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

December 30, 2023

Study Completion Date

September 15, 2024

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)."

Trial Locations (8)

37044

CHRU Tours, Tours

Unknown

Chu Grenoble, Grenoble

Chu Montpellier, Montpellier

Ghr Mulhouse, Mulhouse

CHU NICE, Nice

Nimes, Nîmes

Chu Toulouse, Toulouse

Turkey, Ankara

All Listed Sponsors
collaborator

International Clinical Trials Association

OTHER

lead

Thuasne

INDUSTRY

NCT04203069 - Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase | Biotech Hunter | Biotech Hunter