NCT03579901进行中（未招募）不适用
Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
Motiva USA LLC58 个研究点 分布在 3 个国家目标入组 800 人开始时间: 2018年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 58
- 主要终点
- Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
研究概览
简要总结
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
详细描述
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Genetic female.
- •Patient is seeking one of the following procedures:
- •Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction
- •Patient has adequate tissue available to cover implant(s).
- •Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
- •Agrees to have device returned to Establishment Labs if explanted.
- •Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.
排除标准
- •Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
- •Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
- •Has an abscess or infection.
- •Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment.
- •Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications.
- •Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications.
- •Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others.
- •Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
- •Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure.
- •Has been implanted with any non-FDA approved breast implant.
- •Has been implanted with any silicone implant other than breast implants.
- •HIV positive (based on medical history).
- •Has been diagnosed with anaplastic large cell lymphoma (ALCL).
- •Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.
结局指标
主要结局
Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event.
时间窗: 10 Years
Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.
时间窗: 10 Years
次要结局
- Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture(10 Years)
- Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)(10 Years)
- Patient Satisfaction with Breast (BREAST-Q™) Questionnaire(10 Years)
- Physician Satisfaction (5-point Likert scale)(10 Years)
- Validated Quality of Life questionnaires(10 Years)
- Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline(10 Years)
- Kaplan-Meier analysis of all complications, including reoperation and explantation(10 Years)
- Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms(10 Years)
- Kaplan-Meier analysis of rupture.(10 Years)
研究者
研究点 (58)
Loading locations...
相似试验
已完成
不适用
Safety and Performance Study of the Moderato SystemHypertension Resistant to Conventional TherapyBradycardiaAtrioventricular BlockNCT02282033BackBeat Medical Inc57
Unknown
不适用
First in Man Study of Implantable Alginate HydrogelHeart FailureNCT04781660Xijing Hospital10
Unknown
1 期
Implantation of Peripheral Stem Cells in Patient With Ischemic CardiomyopathyHeart FailureNCT01615250Odessa National Medical University50
尚未招募
不适用
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.Adenoidal DisorderOtorhinolaryngologic DiseasesNasal DiseaseTonsillitisNCT06478433Pharmaluce srl90
招募中
不适用
Assessing the Usability and Reliability of the Prototype Prosthesis DevicesAmputationTraumatic AmputationsLeg AmputationNCT06616402Fondazione Don Carlo Gnocchi Onlus15