Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264817
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-06
Brief Title:
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema
Sponsor:
Thuasne
Organization:
Thuasne
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LyberT
Brief 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
Detailed Description:
The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages Indeed bandages are not easy to put on requiring specific patients skills andor assistance which is not optimal for long-term compliance Moreover they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life For all these reasons described even if bandaging is the current reference of lymphedema treatment they have disadvantages
The day-time elastic compressive armsleeves are proposed as an alternative to bandages However whatever their standard or custom-made design they cannot adapt to limb volumemorphology evolution on the long-term management of this chronic disease because they are not adjustable Therefore as the comfort of treatment is very important in improving compliance armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan
In order to optimize treatment of lymphedema efficacy THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology
The day-time elastic compressive armsleeves are proposed as an alternative to bandages However whatever their standard or custom-made design they cannot adapt to limb volumemorphology evolution on the long-term management of this chronic disease because they are not adjustable Therefore as the comfort of treatment is very important in improving compliance armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan
In order to optimize treatment of lymphedema efficacy THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None