Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.
研究概览
简要总结
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction. The study hypothesis is that patient controlled expansion will lead to rapid and more comfortable outcomes than historical precedents.
详细描述
Title: Patient Activated Controlled Expansion (PACE) for Breast Reconstruction Utilizing Controlled CO2 Inflation
Design: Prospective, open-label, single-arm, feasibility trial Purpose: To evaluate the AirXpanders tissue expander in patients undergoing breast reconstruction surgery following mastectomy.
Enrollment: This feasibility trial will enroll up to 10 patients. Following enrollment of the first 5 patients, the sponsor will determine if additional subjects will be recruited to further evaluate treatment outcome.
Clinical Sites: Up to 3 sites and 3 surgeons will participate in this study. The surgeon(s) should have the necessary qualifications and sufficient experience (minimum of 12 breast tissue expanders placed per year) to participate in the trial.
Duration of Patient Participation: Eligible patients will be enrolled over approximately 2 months.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between the ages of 18 and 65 years.
- •Planned breast reconstruction surgery post-mastectomy.
- •Able to provide informed consent.
- •Able to understand protocol components.
排除标准
- •Tissue at the intended expansion site is determined unsuitable by the surgeon (i.e., infection, compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope, previous radiation treatment, active ulceration)
- •Residual gross tumor at the intended expansion site
- •History of or planned adjuvant radiation therapy
- •Co-morbid condition determined by the surgeon to pose unduly high risk of surgical and/or postoperative complications.
- •Obesity with BMI of 30 or above
- •Current smoker
- •Psychologically unsuitable patient
- •Patient unable to understand the protocol for tissue expansion
- •Planned flight or assent to altitude exceeding 1000 meters above baseline during the expansion period.
研究组 & 干预措施
Post-mastectomy
Post-mastectomy patients undergoing expander reconstruction
干预措施: Patient Activated Controlled Expansion Device (Device)
结局指标
主要结局
Expansion to and maintenance of clinically desired breast volume (not exceeding implant maximum) until permanent implant placement or 6 months (whichever comes first) unless prohibited by a non-device related failure.
时间窗: 6 months
次要结局
- Overall surgeon treatment satisfaction.(6 months)
- Safety as evidenced by a low incidence of device-related adverse events.(6 months)
- Time required to achieve desired expansion results.(6 months)
- Overall patient treatment satisfaction.(6 months)