NCT06013514

Post-market Prospective Clinical Study of Nagor Perle Mammary Implants

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: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: GCA (Eurosilicone) · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Reconstruction
• Breast Reconstruction Following Mastectomy
• Breast Revision
• Breast Augmentation
• Breast Reconstruction With Silicone Implants
• Breast Reconstruction After Mastectomy
• Breast Reconstruction Surgery
• Breast Implants

Interventions

Type	Name	Description
DEVICE	PERLE Sterile Smooth Opaque gel filled mammary implants	Sterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs

Timeline

• Start date: 2024-06-01
• Primary completion: 2038-09-01
• Completion: 2038-09-01
• First posted: 2023-08-28
• Last updated: 2025-07-11

Locations

1 site across 1 country: United Kingdom