NCT01903174已完成不适用
AeroForm Patient Controlled Tissue Expansion for Breast Reconstruction
AirXpanders, Inc.2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
研究概览
简要总结
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
详细描述
The objective of this study is to provide performance and safety data to support the clinical use of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction in a patient population with a broad selection criteria
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
- 否
入选标准
- •Subject is female between the ages of 18 -
- •Subject has elected two stage breast reconstruction with tissue expanders.
- •Subject's tissue is amenable to tissue expansion.
- •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 has residual gross malignancy following mastectomy.
- •Subject has a current infection at the intended expansion site.
- •Subject has clinically significant radiation fibrosis at the expansion site.
- •Subject has planned radiation at the intended expansion site during the time the expander is implanted.
- •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 currently participating in a concurrent investigational drug or device study.
- •Subject is a current tobacco smoker.
- •Subject is overweight with a BMI >
- •Subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.
- •Subject is pregnant or planning to become 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 Permanent Breast Implant unless Precluded by a Non-Device Related Event
时间窗: 6 months
次要结局
- Adverse Events related to the Breast Reconstruction Procedure(6 months)
研究者
研究点 (2)
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