A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two Stage Prepectoral Breast Reconstruction Post-Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 44
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
- •Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.
排除标准
- •Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
- •Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
研究组 & 干预措施
Acellular Dermal Matrix
Breast reconstruction with ARTIA Tissue Matrix.
干预措施: ARTIA Reconstructive Tissue Matrix (Device)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately 36 Months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a medical device which does not necessarily have a causal relationship with this treatment.
Occurrence of at Least One Major Complication related to Breast Reconstruction After Stage 1
时间窗: Month 18
Number of participants with at least one major complication related to breast reconstruction.
Change from Baseline in BREAST-Q Satisfaction with Breasts Score from Pre-Mastectomy After Stage 2
时间窗: Up to Month 18
Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.
次要结局
- Occurrence of Capsular Contracture per Breast(Month 36)