Post-market Prospective Clinical Study of Nagor Perle Mammary Implants (NCT06013514) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
United Kingdom60 participantsStarted 2024-06-01
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Genetic female subjects aged ≥18 and ≤65
✓. Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:-
Exclusion criteria
✕. Subjects undergoing implant augmentation with a BMI \> 30 and undergoing reconstruction with a BMI \>32.
✕. 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.
✕. Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer related clinical studies.
✕. 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.
. 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.
✕. Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
✕. 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.