Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303154
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-04
Brief Title:
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment
Sponsor:
Thuasne
Organization:
Thuasne
Study Overview
Official Title:
Evaluation of the Performance and Safety of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment - A Prospective Exploratory Monocentric Uncontrolled Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
MOBIBRA
Brief Summary:
The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment
Detailed Description:
Breast cancer is the most common malignancy in women in the Western World BCS followed by radiotherapy is a safe and effective procedure to treat patients with early-stage Verbelen H 2021 But some patients are troubled by breast edema in the operated and irradiated breast The consequences of breast edema can be an increase in breast volume orange peel skin heaviness of the breast redness of the skin breast pain thickening of the skin hyperpigmented skin pores Verbelen H 2014 Breast edema can also imply deterioration in patients quality of life physical functioning and body image Young-Afat D A 2019
According to the literature only a few clinical studies evaluated the value of compression medical devices in the management of breast edema
The aim of the study is to perform a prospective exploratory monocentric uncontrolled clinical study to look at the performance and safety of Mobiderm Intimate Bra in the management of breast edema related to breast cancer treatment
According to the literature only a few clinical studies evaluated the value of compression medical devices in the management of breast edema
The aim of the study is to perform a prospective exploratory monocentric uncontrolled clinical study to look at the performance and safety of Mobiderm Intimate Bra in the management of breast edema related to breast cancer treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2023-A01937-38 | None |