NCT06146231招募中不适用
Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Total adverse envent rate
研究概览
简要总结
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
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
- 否
入选标准
- •Genetically female, aged 18 years or older.
- •Subjects who had provided written informed consent form.
- •The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.
- •Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.
- •Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
- •Complete radiotherapy and chemotherapy at least one year before surgery.
- •BMI between 18.5 and 30.0 (average classified weight).
- •Physical and cognitive capacity to understand and follow the surgeon's recommendations.
- •To be able and willing to comply with all study requirements, including attending follow-up appointments.
- •Only Sub study participants
- •Provide additional consent to undergo an MRI with contrast.
排除标准
- •Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.
- •Abnormal hematological and biochemical values after chemotherapy.
- •High surgical risk according to the investigator.
- •Breast width larger than 18 cm
- •Tumor residues in or near the area where tissue expansion is performed.
- •Subjects with metastatic breast cancer
- •Significant Breast ptosis or poor skin quality
- •Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or mastectomy scar deformity.
- •Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
- •Current or previous infection in the area where the expansion occurs.
- •Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
- •Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
- •History of silicone sensitivity.
- •Active smokers
- •Previous attempts of breast reconstruction
- •Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
- •Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
- •Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
- •Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study
结局指标
主要结局
Total adverse envent rate
时间窗: 46 months
This variable will be assessed by the total incidence, seriousness, severity, causal relationship with the device, measure(s) taken for resolution, outcome, and duration of the various adverse events (AEs) reported during the surgery and follow-up period. The incidence of AEs, in terms of percentage, will be evaluated statistically with a 95% confidence interval. The analysis of the AEs will include: * All AEs reported during the time period in which Motiva Flora® TE remains implanted (up to a maximum of 16 months) * All AEs reported during the conduct of the whole clinical investigation (reconstruction process and 24 months follow-up)
次要结局
- Device's performance: Device integrity(6-16 months)
- Surgeon's overall satisfaction(46 months)
- Patient's anxiety and depression(46 months)
- Patient's satisfaction and quality of life impact(46 months)
- Changes in breast vascularity(46 months)
- Changes in breast volume(46 months)
研究者
研究点 (6)
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