Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Recruiting
Observational Study
Breast Reconstruction
Breast Reconstruction Following Mastectomy
Breast Revision
Breast Augmentation
Breast Reconstruction With Silicone Implants
Breast Reconstruction After Mastectomy
Breast Reconstruction Surgery
Breast Implants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Study type
- Observational
- Participants needed
- 60 (estimated)
- Sponsor
- GCA (Eurosilicone) · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Genetic female subjects aged ≥18 and ≤65
2. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-
i) Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including pat…
Contacts