Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-05 @ 11:51 AM
Study NCT ID:
NCT03356132
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
Sponsor:
Silimed Industria de Implantes Ltda
Organization:
Study Overview
Official Title:
Post-market Monitoring and Control of Safety and Efficacy of Silimed® Breast Implants with Textured Surface and Polyurethane Foam-coated Surface
Status:
RECRUITING
Status Verified Date:
2024-11
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:
STEPS A
Brief Summary:
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: