AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 33
- 主要终点
- Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
研究概览
简要总结
This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.
详细描述
This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is a woman between the ages of 18-
- •Subject needs to have tissue expansion as part of her breast reconstruction.
- •Subject is able to provide written informed consent.
- •Subject is able and willing to comply with all of the study requirements.
- •Subject is able to understand and manage at home dosing regimen.
排除标准
- •Subjects skin is not suitable for tissue expansion.
- •Subject has remaining tumor cells following her mastectomy.
- •Subject has a current or prior infection at the intended expansion site.
- •Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.
- •4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.
- •Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.
- •Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).
- •Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).
- •Subject is currently participating in a concurrent investigational drug or device study.
- •Subject is a current tobacco smoker.
- •Subject is overweight (BMI > 33).
- •Subject is unwilling to comply with the air travel or altitude restriction of not > 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.
- •Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- •Subject is pregnant or planning on becoming pregnant during the study period.
- •Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.
结局指标
主要结局
Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event
时间窗: 12 months
The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.
次要结局
- Expansion Days(12 months)