A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of implant rupture
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Subjects undergoing implant augmentation with a BMI > 30 and undergoing reconstruction with a BMI >
- •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
研究组 & 干预措施
Smooth Silicone Breast Implant
干预措施: PERLE Sterile Smooth Opaque gel filled mammary implants (Device)
结局指标
主要结局
Rate of implant rupture
时间窗: 10 years post-surgery
Rate of capsular contracture (Baker grade III-IV)
时间窗: 10 years post-surgery
次要结局
- rate and frequency of any adverse events(10 years post-surgery)
- Patient satisfaction(10 years post-surgery)
- Rate of the secondary surgical procedures required for correction of complications(10 years post-surgery)
- Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants(10 years post-surgery)