跳至主要内容
临床试验/DRKS00025856
DRKS00025856
招募中
不适用

ational, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with a single incision, fixation free Self-Retaining Support implant (SRS implant) - PMCF study SRS implant

pfm medical gmbh0 个研究点目标入组 175 人2022年3月3日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
N81
发起方
pfm medical gmbh
入组人数
175
状态
招募中
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2022年3月3日
结束日期
待定
最后更新
去年
研究类型
Observational
性别
Female

研究者

入排标准

入选标准

  • 1\) Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse \= stage II (according to POP\-Q system). This applies to primary as well as recurrent intervention. 2\) Age \= 21 years.
  • 3\) Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
  • 4\) Patient information has been provided and written consent exists.

排除标准

  • 1\) Contraindications according to the manufacturer’s instructions for use.
  • 2\) 2\)Patient with previous urogynaecological surgeries with alloplastic material.
  • 3\) Patient with radiological treatment in the pelvic floor.
  • 4\) Patient is institutionalised by court or official order (MPDG §27\).
  • 5\) Participation in another interventional study concerning pelvic floor reconstruction.

结局指标

主要结局

未指定

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