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.
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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

Nabila Nasir, Dr

(0)161 276 868

pals@mft.nhs.uk

CONTACT