A Retrospective Assessment of OviTex PRS (OviTex) Permanent and Resorbable Devices in Subjects Who Have Previously Undergone a Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Tela Bio Inc
- 入组人数
- 200
- 试验地点
- 22
- 主要终点
- The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
研究概览
简要总结
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast reconstructions.
详细描述
This study is organized as a retrospective-prospective, observational, multi-center study. The treatment group involved in the study received OviTex PRS during implant-based breast reconstruction. The reconstruction procedure was an immediate or two-stage unilateral or bilateral implant in either the sub-pectoral or pre-pectoral position. Results from this study are aimed to demonstrate an acceptable safety profile and to inform the study design and effectiveness endpoints of a future prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient was between 18 years and 75 years of age (inclusive) at the time of surgery.
- •At the time of surgery, the patient received an OviTex PRS Permanent (R20143 or R20243) or Resorbable (R20152 or R20252) implant in conjunction with an implant-based breast reconstruction.
- •Patient has undergone their initial surgical procedure and exchange surgery (if applicable).
排除标准
- •Patient received a textured permanent breast implant.
- •Patient was a nicotine user (including smokeless, vaporized, etc.) within 4-weeks preceeding their index procedure.
- •Patient had previously undergone radiation therapy to the chest wall prior to index surgery.
- •Additional prospective inclusion criteria (if applicable):
- •1. Patient agrees to return in-person for prospective portion including the completion of photographs.
- •Additional prospective exclusion criteria (if applicable):
- •1. Patient has a history of a psychological condision, drug or alcohol abuse which may interfere with their ability to adhere to the follow-up requirements.
结局指标
主要结局
The occurrence of relevant (S)AEs within 24 months of OviTex® PRS implantation.
时间窗: 24 months
Retrospective - Prospective assessment
次要结局
- Time to Expander/Implant Exchange(24-months)
- Intraoperative Fill Volume / Number and Volume of Fill Visits(24 months)
- Independent aesthetic assessment of each treated breast as measured by Telemark Breast Score(24 months)
- Independent assessment of breast ptosis as measured by the Rainbow Scale(24-months)
- Hospitalization length of stay(At procedure)