A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
研究概览
简要总结
The study is a single arm, retrospective, single-center, post market registry.
The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
详细描述
CUSA® Excel/Clarity Ultrasonic Surgical Aspirator System is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
- Neurosurgery
- Gastrointestinal and affiliated organ surgery
- Urological surgery
- General surgery
- Orthopedic surgery
- Gynecological surgery
- Laparoscopic surgery
This Registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of CUSA in Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Information obtained from this retrospective Registry will help inform a potential future prospective study for this indication in a real-world population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report.
- •Subject had post-operative visits completed at the gynecologic oncology practice.
- •Subject had surgery with CUSA between January 2010 and December 2022.
排除标准
- •Not Applicable
结局指标
主要结局
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
时间窗: During Surgery
Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
次要结局
- Primary Site Recurrence(Up to 12 months Postoperatively.)