NCT02190825已完成不适用
Safety and Efficacy Study of the NeuGuide Device
Pop Medical Solutions2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年11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
- 15
- 试验地点
- 2
- 主要终点
- Stage of pelvic floor prolapse as defined by POP-Q score
研究概览
简要总结
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP).
Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system.
Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18-80 years old
- •POP-Q stage III prolapse or higher
- •Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device
- •Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol
排除标准
- •Exclusion Criteria:
- •Diagnosis of reproductive tract anomalies
- •Prior pelvic radiation therapy or any malignancy
- •Inability to complete written questionnaires.
- •Women with significant Pelvic Inflammatory Disease (PID) history
- •Women with known allergy to Nickel or Nitinol
结局指标
主要结局
Stage of pelvic floor prolapse as defined by POP-Q score
时间窗: 6 months
Complications (SAE, AE)
时间窗: Up to 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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