Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544304
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Buttock Augmentation With Polymethylmethacrylate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interventional Multicenter Single-Arm Clinical Trial of Buttock Augmentation With Polymethylmethacrylate
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single-arm multicenter interventional clinical trial of buttock augmentation with polymethyl methacrylate
The objective is to evaluate the safety and effectiveness of using 30 Biosimetric PMMA gel for buttock augmentation
The objective is to evaluate the safety and effectiveness of using 30 Biosimetric PMMA gel for buttock augmentation
Detailed Description:
The sample will be 133 patients Specific patients will be screened at study sites according to eligibility classifications After signing the consent form patients will be included in the study and will be monitored for 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None