NCT02209337已完成不适用
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Lyra Medical Ltd.5 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2014年9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
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- No device related serious adverse events
研究概览
简要总结
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
- •Patient age is between 18 and 75 years old
- •POP-Q: Aa and/or Ba is at least -1
排除标准
- •Patient is pregnant or breastfeeding
- •Patient suffering from active infection (on antibiotic therapy)
- •Patient planning vaginal delivery
- •Patient had Previous vaginal mesh surgery
- •Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
- •Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
- •Malignancy .
- •Known hypersensitivity to PEEK and polypropylene materials.
- •Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- •Tendency for hyper-scaring reaction
- •Diagnosed with mental or emotional disturbance.
研究组 & 干预措施
SRS-I
Experimental
Implantation of SRS-I
干预措施: SRS (Device)
结局指标
主要结局
No device related serious adverse events
时间窗: up to 12 month
次要结局
- Achieving normal urinary function(up to 12 months)
- Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)(up to 12 months)
- Improvement in POP-Q: points Aa and Ba(up to 12 month)
- Improvement in POP-Q point C(up to 12 months)
研究者
研究点 (5)
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