AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (XPAND-II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
研究概览
简要总结
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
详细描述
This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is female between the ages of 18-70
- •Subject requires tissue expansion as part of breast reconstruction
- •Subject is able to provide written informed consent
- •Subject is able and willing to comply with all of the study requirements
- •Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen
排除标准
- •Subject's tissue integrity is unsuitable for tissue expansion
- •Subject has residual gross malignancy at the intended expansion site
- •Subject has current or prior infection at the intended expansion site
- •Subject has a history of failed tissue expansion or breast reconstruction
- •Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
- •Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).
研究组 & 干预措施
AeroForm Tissue Expander
AeroForm Tissue Expansion inflation with carbon dioxide by remote control
干预措施: AeroForm Tissue Expander (Device)
结局指标
主要结局
Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event
时间窗: 6 months
The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.
次要结局
- Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.(6 months)