A prospective, multi-center, observational, non-comparative, postmarketing surveillance study to obtain clinical outcome data on the Nagor PERLE™ range of silicone breast implants when used in breast augmentation or reconstruction for women from 18 to 65 years

agor Ltd0 sites700 target enrollmentSeptember 8, 2023

ConditionsBreast surgery: augmentation and reconstruction including revision for women Surgery

Overview

Phase: 未知
Intervention: Not specified
Conditions: Breast surgery: augmentation and reconstruction including revision for women
Sponsor: agor Ltd
Enrollment: 700
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 8, 2023

End Date

December 31, 2035

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

agor Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Genetic female subjects aged \=18 and \=65 years
•2\. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
•2\.1\. Primary breast reconstruction following mastectomy (both for one\-stage or two\-stage surgeries, including patients with previous radiotherapy and who have ADMs of animal origin (bovine, porcine)).
•2\.2\. Primary breast augmentation (cosmetic surgery) with or without mastopexy
•2\.3\. Breast revision surgery with or without mastopexy
•3\. Subjects who have received a Nagor PERLE implant.
•4\. Subjects who have provided informed consent and can adhere to the requirements of follow\-up appointments as per the study protocol.

Exclusion Criteria

•1\. Subjects undergoing implant augmentation with a BMI \> 30 and undergoing reconstruction with a BMI \>32
•2\. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
•3\. Subjects who have participated in a clinical study which involves chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies
•4\. Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle
•5\. Subjects who have ADMs of synthetic origin
•6\. Subjects who, in the Investigator’s clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant
•7\. Subjects with a known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery
•8\. Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator
•9\. Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery
•10\. Subjects with a known history of compromised wound healing