Motiva Mia® Pilot Study to Evaluate the Safety and Initial Effectiveness of the Procedure and System Devices, Including Motiva Implants® Ergonomix2 Diamond® in Subjects Undergoing Primary Breast Augmentation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon.
详细描述
This is a prospective follow-up, 36-month, open, interventional study to confirm the safety and effectiveness of the procedure and system devices, including Motiva® Ergonomix2 Diamond® implants in women subjected to primary breast augmentation.
This study will enroll 100 women who will undergo a minimally invasive breast augmentation procedure with Ergonomix2 Diamond® using Motiva Injector® MIA and the Motiva MIA® inflatable balloon. The study duration will be 36 months and a six-month enrollment window was planned.
Recruitment will take place after enrollment and before any clinical research procedures, a participant will sign and date the Informed Consent Form. This will be considered the intent-to-treat (ITT) population. Since there will be a subset of women who will provide their consent to participate but will not undergo the procedure (i.e., due to a screening failure or consent withdrawal before the surgery, the analysis population for this study will be the full analysis set ("treated population") which will be made up by women that have received the implant(s) and that have at least one postop evaluation.
A Magnetic Resonance Imaging (MRI) substudy will be performed to determine the rate of silent rupture (no signs or symptoms) both extra- and intracapsular, and to identify displacement and/or gel fracture. MRI scans in this study will be performed on participants who are 18 to 21 months post-op. However, any study participant, whether or not participating in this sub study, who presents with signs or symptoms suggestive of a rupture, will be referred for MRI evaluation at any time during the study. Information obtained from the MRI study will be collected on the MRI Case Report Form by the investigator.
The proposed sample size of 33 participants in the MRI substudy, considered to be the industry standard, one third of the total sample participating in the Motiva MIA® study, and who consent to participate in this substudy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Genetic females, ≥ 18 years.
- •AA to C cup size, evaluated according to Triumph international guidelines.
- •Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA)
- •Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size.
- •Body Mass Index between 18.5 and 24.9 (normal weight).
- •Adequate tissue for covering the implant(s).
- •Willingness to follow all study requirements and attending all necessary follow-up visits.
- •Agreement to return the device to the sponsor in case it is explanted
排除标准
- •Current costal lesions.
- •Breast ptosis or poor skin quality.
- •Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring).
- •History of abscesses or infections in the breast area.
- •Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment.
- •History of silicone sensitivity.
- •Use of any medications that interfere with coagulation or that may imply a high risk and/or significant post-surgical complication.
- •Any medical condition, such as low weight or obesity according to the inclusion criteria, diabetes, autoimmune disease, chronic lung disease or serious cardiovascular disease that may result in an excessively high surgical risk and/or important post-surgical complications.
- •Any condition that precludes the use of magnetic resonance imaging (MRI), including implanted metal devices, claustrophobia or other conditions that preclude MRI exploration.
- •Any history of psychological characteristics that are not realistic or reasonable, considering the risks involved with the surgical procedure.
- •Use of any medications that, according to the investigator, may imply a higher risk of complications or interference with wound healing ability, such as corticosteroids or anticoagulants (i.e., concomitant warfarin therapy).
- •Current participation on studies for investigation devices or pharmaceutical products.
- •Participants not residing in Costa Rica, which precludes their attendance to follow-up visits.
- •Sponsor (or any of its subsidiaries) employees, study investigator or any person helping to conduct the study; direct (family) relationship with any sponsor (or any of its subsidiaries) or investigator employees.
结局指标
主要结局
Safety
时间窗: From minimally invasive procedure through study completion, an average of 3 years.
Cumulative incidence (number of cases) of adverse events during surgery and the follow-up period, severity and duration of all complications (rate of adverse events related to the procedure / adverse events related to the device).
Effectiveness
时间窗: From minimally invasive procedure through study completion, an average of 3 years.
Effectiveness will be measured as satisfactory on all breast augmentation procedures using Mia® devices if no device failures have occurred.
次要结局
- Surgeon satisfaction(During minimally invasive procedure)
- Patient satisfaction(From week 1 post-procedure to the end of the follow-up period)