NCT07679594招募中不适用
A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.
GCA (Eurosilicone)2 个研究点 分布在 2 个国家目标入组 650 人开始时间: 2026年3月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Frequency and rate of implant rupture
研究概览
简要总结
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.
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
- 是
入选标准
- •The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.
- •Inclusion criteria are:
- •Genetic female subjects aged between 18 and 65 years old.
- •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 (synthetic or natural).
- •ii. Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna 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 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, 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
Aesthetic indications
Primary or revision breast augmentation with or without mastopexy.
干预措施: Breast augmentation surgery (Procedure)
Medical indications
Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy.
干预措施: Breast reconstruction surgery (Procedure)
结局指标
主要结局
Frequency and rate of implant rupture
时间窗: 10 years
Frequency and rate of capsular contracture Baker III-IV
时间窗: 10 years
次要结局
- Rate of the secondary surgical procedures required for correction of complications(10 years)
- Patient satisfaction(10 years)
- Rate and frequency of local complications(10 years)
研究者
研究点 (2)
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