NCT06938399招募中不适用
Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures
Motiva USA LLC52 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2025年5月1日最近更新:
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
- 2,400
- 试验地点
- 52
- 主要终点
- Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants
研究概览
简要总结
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
详细描述
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Motiva Implants®:
- •Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation
- •Patient has adequate tissue available to cover implant(s)
- •Willingness to follow all study requirements
- •Signs an Informed Consent
- •Agrees to have device returned to the Sponsor, if explanted
- •Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised
- •Inclusion Criteria Control group:
- •Is 22 years of age or older
- •Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)
- •Signs an Informed Consent
- •Willingness to follow all study requirements
排除标准
- •Motiva Implants®:
- •Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2
- •Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)
- •Has an active infection anywhere in their body
- •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 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 Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
- •Exclusion Criteria Control group:
- •Has a history of silicone implants (anywhere in the body)
- •Plans to undergo silicone breast implant surgery during the course of the study
- •Has an active infection anywhere in their body
- •Has a history of cancer (except skin cancer)
- •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
研究组 & 干预措施
Primary Augmentation
Other
Subjects age 22 and over, indicated to increase breast size
干预措施: Silicone gel-filled breast implants - Motiva Implants® (Device)
Revision Augmentation
Other
Revision surgery to correct or improve the results of a previous breast augmentation
干预措施: Silicone gel-filled breast implants - Motiva Implants® (Device)
Control Group
Other
Aesthetic procedure other than breast implant surgery
干预措施: Aesthetic Surgery (Other)
结局指标
主要结局
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants
时间窗: 10 Years
Analysis of Patient-Reported incidence of Connective Tissue Diseases (CTDs) and related systemic symptoms, collected through a questionnaire that includes the PROMIS-29 Survey
次要结局
- Investigate the incidence of Reproductive Complications, Cancer Diagnoses, Local Complications in Motiva implanted participants compared to the incidence in control participants, where data collection allows; and investigate patient satisfaction(10 Years)
- Assess the impact of RFID on imaging(10 Years)
研究者
研究点 (52)
Loading locations...
相似试验
进行中（未招募）
不适用
Study of the Safety and Effectiveness of Motiva Implants®Breast ImplantsNCT03579901Motiva USA LLC800
已完成
不适用
Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft SystemAortic Aneurysm, AbdominalNCT01980901TriVascular, Inc.320
已完成
不适用
Safety and Performance of Motiva® SizersMammaplastyBreast ReconstructionBreast AugmentationBreast Implantation Methods, Safety and PerformanceBreast Implant ComplicationsNCT06274736Establishment Labs133
已完成
不适用
PMCF Study for Peripheral Arteries Below the Knee (BTK)Peripheral Artery DiseaseNCT05444660Cordis Corporation102
进行中（未招募）
不适用
Zimmer Trabecular Metal Total Ankle PMCFDegenerative ArthritisRheumatoid ArthritisPost Traumatic ArthritisNCT02038140Zimmer Biomet120