A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
• Volume difference between affected and healthy arm ≥ 10%
• Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.
• Signed informed consent prior to any study-mandated procedure.
Locations
Other Locations
Turkey
ANKARA
RECRUITING
Ankara
Pinar BORMAN
RECRUITING
Ankara
Contact Information
Primary
Burcu DUYUR ÇAKIT, MD
burcudcakit@gmail.com
0533 654 24 55
Backup
ASTRID PICOLET
astrid.picolet@thuasne.fr
0640392490
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2025-04-15
Participants
Target number of participants: 40
Treatments
Active_comparator: Control group : compressive bandaging
Control group : compressive bandaging:~* Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice~* Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night
Experimental: Intervention group: MOBIDERM Autofit Armsleeve
Intervention group: MOBIDERM Autofit Armsleeve~* Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time)~* Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night
Related Therapeutic Areas
Sponsors
Leads: Thuasne