Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013514
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-22
Brief Title:
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Sponsor:
GC Aesthetics
Organization:
GC Aesthetics
Study Overview
Official Title:
A Prospective Multi-center Observational Non Comparative Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
PERLE10PMCF
Brief Summary:
Patients can undergo breast implant surgery for multiple reasons cosmetic and reconstructive being the primary indications In order to confidently state safety and due to strict regulation on medical devices it is important to maintain a record of safety and performance with all medical implants
This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant
The two main complications of breast implants are capsular contracture and rupture these complications can take years to develop The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3 5 8 and 10 years thereafter
The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications
This study is designed to collect data on a new generation of smooth mammary implants to assess the long term performance and safety data on this type of gel-filled mammary breast implant
The two main complications of breast implants are capsular contracture and rupture these complications can take years to develop The study is designed to evaluate the occurrence of these two primary complication as well as other secondary complications over a period of 10 years Patient follow up will be carried out pre-operatively and post operatively at 12 months and then 3 5 8 and 10 years thereafter
The study will be carried out over 10 years to adequately assess complications which may only occur over the lifetime of the device such as systemic complications
Detailed Description:
None
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