Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-02 @ 6:39 AM
Study NCT ID:
NCT04203069
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase
Sponsor:
Thuasne
Organization:
Study Overview
Official Title:
Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study
Status:
COMPLETED
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:
LYMphoNIGHT
Brief 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.
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.
Detailed Description:
The gold standard treatment to achieve volume reduction of lymphedema is based on a Decongestive Lymphedema Therapy (DLT).that consists in 2 consecutive phases: the initial intensive phase which aim is to obtain maximal reduction of lymphedema volume and a second, the maintenance phase which aim is to maintain the initial volumetric reduction achieved during phase 1 as long as possible. The second maintenance phase mostly based on patient self-management of his treatment, is not strictly codified, but includes compression therapy, nutritional recommendations, skin cares, physical exercises and manual lymphatic drainage.
24 hours compression using garments or bandages seems to be crucial for long term management of lymphedema.
Garment and bandages prescriptions for daily treatment are a common practice in the maintenance phase but are often unsuitable for night treatment, as bandages are effective when well applied but are highly dependent on the patients' skills, and garments, due to their nature, can be poorly tolerated leading to low adherence from patients to self-management care. In the end, there is an unmet medical need for night treatment during maintenance phase. .
In this context THUASNE developed a specific night-time garment, for lymphedema maintenance phase. It is a standard Auto-Adjustable Armsleeve using the MOBIDERM® technology.
MOBIDERM® AUTOFIT is a standard self-adjusting compressive MOBIDERM® sleeve, with mitten.
Several small rigid straps are placed throughout the product to facilitate the passage of the arm, to adapt the garment to the morphology of each patient and to tighten it.
A first pilot randomized controlled study demonstrated some benefit to use MOBIDERM Autofit during night-time as an adjuvant treatment to daily compressive garment.
The objective of this new study is to confirm, using a more robust methodology, the effect of Auto-Adjustable MOBIDERM® Autofit Armsleeve on maintenance phase treatment, worn during the night, within the period at risk for the so called rebound effect as reported in several observational studies.
24 hours compression using garments or bandages seems to be crucial for long term management of lymphedema.
Garment and bandages prescriptions for daily treatment are a common practice in the maintenance phase but are often unsuitable for night treatment, as bandages are effective when well applied but are highly dependent on the patients' skills, and garments, due to their nature, can be poorly tolerated leading to low adherence from patients to self-management care. In the end, there is an unmet medical need for night treatment during maintenance phase. .
In this context THUASNE developed a specific night-time garment, for lymphedema maintenance phase. It is a standard Auto-Adjustable Armsleeve using the MOBIDERM® technology.
MOBIDERM® AUTOFIT is a standard self-adjusting compressive MOBIDERM® sleeve, with mitten.
Several small rigid straps are placed throughout the product to facilitate the passage of the arm, to adapt the garment to the morphology of each patient and to tighten it.
A first pilot randomized controlled study demonstrated some benefit to use MOBIDERM Autofit during night-time as an adjuvant treatment to daily compressive garment.
The objective of this new study is to confirm, using a more robust methodology, the effect of Auto-Adjustable MOBIDERM® Autofit Armsleeve on maintenance phase treatment, worn during the night, within the period at risk for the so called rebound effect as reported in several observational studies.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ANSM | OTHER | 2019-A02216-51 | View |