NCT06456554
招募中
不适用
Acellular Dermal Matrix Investigation in Breast Reconstruction
概览
- 阶段
- 不适用
- 干预措施
- no Acellular Dermal Matrix
- 疾病 / 适应症
- Breast Reconstruction
- 发起方
- RTI Surgical
- 入组人数
- 467
- 试验地点
- 11
- 主要终点
- Health related quality of life
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
研究者
入排标准
入选标准
- •Genetic female
- •Age 22 or older at time of consent
- •Undergoing immediate breast reconstruction
- •2 stage breast reconstruction using pre pectoral technique
- •Nipple or skin sparing mastectomy
- •Willing and capable of providing informed consent
- •Able to comply with study requirements
排除标准
- •Planned concurrent reconstruction with pedicled flaps or free tissue
- •Pregnant or breast feeding
- •Investigator has determined tissue is unsuitable for two-stage breast reconstruction
- •History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
- •Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
- •Vulnerable subject populations
- •Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
- •Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
- •Active abscess or infection in the intended reconstruction site
- •Residual gross tumor at the intended reconstruction site
研究组 & 干预措施
no Acellular Dermal Matrix
Breast reconstruction only with no ADM
Acellular Dermal Matrix
Breast reconstruction with Cortiva Tissue Matrix
干预措施: Acellular Dermal Matrix (Cortiva Tissue Matrix)
结局指标
主要结局
Health related quality of life
时间窗: 12 months
Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Rate of major adverse events
时间窗: 12 months
Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
次要结局
- Histopathology assessment(stage 2 procedure)
- Investigational device related adverse events(3 months, 1 year and 2 years)
- Change in quality of life(1 year and 2 years)
- Procedure related adverse events(3 months, 1 year and 2 years)
研究点 (11)
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