DRKS00010001已完成未知
ational, multicentre post market surveillance study on anterior pelvic prolapse reconstruction with a titanium-coated polypropylene mesh (TiLOOP® PRO A) - TiLOOP® PRO A
pfm medical ag0 个研究点目标入组 54 人开始时间: 2016年3月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •1. Existence of a cystocele. Women with a symptomatic genital descensus: at least
- •stage II (ICS-classification according POP-Q system). This applies to primary as
- •well as recurrent intervention.
- •2. Patient is mentally able to understand the nature, aims, or possible
- •consequences of the clinical investigation.
- •3. Patient information has been handed out and written consent is at hand.
- •4. Patient has attained full age (18 years or older).
排除标准
- •1. Unfinished family planning, pregnancy or breast-feeding mother.
- •2. Known intolerance to the mesh-implants under investigation.
- •3. Lack of written patients’ informed consent.
- •4. Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
- •5. Patients with acute (within the last 12 months) carcinoma in the pelvic area.
- •6. Patients with history of radiotherapy in the pelvic area.
- •7. Patients with implanted anterior pelvic floor mesh.
- •8. Patient is institutionalized by court or official order (MPG §20.3).
- •9. Participation in another interventional clinical investigation.
研究者
相似试验
已完成
不适用
Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a CraniotomyPatients scheduled for craniotomy that entails dural incision.JPRN-UMIN000007147Covidien Japan Inc.140
已完成
4 期
Clinical outcome and fusion rates after surgery with TM Ardis interbody fusion systemSpondylolisthesisISRCTN89404187Zimmer Spine (France)80
进行中（未招募）
不适用
A PMS study to assess the safety and reactogenicity of GSK Biologicals’ DTPa-IPV/Hib and INFANRIX HEXA™ vaccines when administered as a primary vaccination course, followed by admini-stration of GSK Biologicals’ DTPa-IPV/Hib vaccine as a booster dose in toddlers.EUCTR2012-002439-26-Outside-EU/EEAGlaxoSmithKline Biologicals702
已完成
不适用
Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNiousN81.1N81.2CystoceleIncomplete uterovaginal prolapseDRKS00011657A.M.I. GmbH (Agency for Medical Innovations)254
已完成
不适用
A Multicenter, Post-Market Observational (non-interventional) Study of SUPARTZ in Subjects with Osteoarthritis of the Knee or Periarthritis of the ShoulderOsteoarthritis of the Knee or Periarthritis of the ShoulderJPRN-UMIN000038272SEIKAGAKU CORPORATIO60