Status:
RECRUITING
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Lead Sponsor:
GC Aesthetics
Conditions:
Breast Reconstruction
Breast Reconstruction Following Mastectomy
Eligibility:
FEMALE
18-65 years
Brief 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 medica...
Eligibility Criteria
Inclusion
- 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:-
- i) 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)). ii) Primary breast augmentation (cosmetic surgery) with or without mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have received a Nagor PERLE implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow up appointments as per the study protocol.
Exclusion
- 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 have ADMs of synthetic origin.
- 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.
- Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
- Subjects with a known history of compromised wound healing.
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants
- Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant
Key Trial Info
Start Date :
June 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2038
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06013514
Start Date
June 1 2024
End Date
September 1 2038
Last Update
July 11 2025
Active Locations (1)
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1
NHS Manchester
Manchester, United Kingdom, United Kingdom, M13 9WL