NCT02033590撤回不适用
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
Sofregen Medical, Inc.0 个研究点开始时间: 2014年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Incidence rate of implant loss (SERI® and breast implant)
研究概览
简要总结
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
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
- •Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
- •Be female, between 18 and 65 years of age at the time of enrollment
排除标准
- •Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
- •Have undergone a skin reducing mastectomy
- •Have a BMI that is <17 or ≥ 30
- •Predicted implant weight more than 500 grams
- •Have a known allergy to silk
- •Have an abscess or active infection at any location within one month prior to surgery
- •Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study
研究组 & 干预措施
SERI® Surgical Scaffold
Experimental
干预措施: Biodegradable (purified) surgical silk scaffold (Device)
结局指标
主要结局
Incidence rate of implant loss (SERI® and breast implant)
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
不适用
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF AblationAtrial ArrhythmiaArrhythmias, CardiacAtrial FibrillationNCT06083012Volta Medical186
已完成
不适用
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal SurgeryColonic DiseasesNCT01610726Haukeland University Hospital484
撤回
不适用
Study of the Effect on Clinical Outcomes Using Secure Text MessagingDiabetesCopdRenal FailureCongestive Heart FailureNCT02568514University of Pennsylvania
尚未招募
不适用
Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell CarcinomasBasal Cell Carcinoma of the SkinNCT06271603Damae Medical704
已完成
不适用
FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements StudyKidney Failure, ChronicEnd Stage Renal Disease, Requiring DialysisNCT00288613NxStage Medical501