Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-06 @ 6:19 PM
Study NCT ID:
NCT06544304
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buttock Augmentation With Polymethylmethacrylate
Sponsor:
MTC MEDICAL COMERCIO INDUSTRIA IMPORTACAO E EXPORTACAO DE PRODUTOS BIOMEDICOS LTDA
Organization:
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:
False
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:
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?: