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临床试验/NCT01823055
NCT01823055已完成不适用

Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial

Karolinska Institutet0 个研究点目标入组 214 人开始时间: 2012年1月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
214
主要终点
Immediate and delayed complications related to the surgical procedure
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 —（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification [POP-Q] system)9,
  • •with or without anterior vaginal wall prolapse, and
  • •experiences symptoms of vaginal bulging with or without a previous hysterectomy
  • •being able to provide oral and written informed consent before entering the study.

排除标准

  • •previous cancer of any pelvic organ,
  • •systemic glucocorticoid treatment,
  • •insulin-treated diabetes,
  • •an inability to participate in study follow-up or to provide informed consent, or
  • •the need for any concomitant pelvic surgery.

结局指标

主要结局

Immediate and delayed complications related to the surgical procedure

时间窗: 1 year

Serious surgical complications are categorised as any surgical event which is potentially life-threatening, internal organ perforation (or other injury), bleeding in excess of 1000 mL or adverse events, related to the surgical procedure, during follow-up which requires re-hospitalisation.

次要结局

  • Pelvic Organ Prolapse Quantification system(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Altman

Md, PhD, Associate professor

Karolinska Institutet

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Safety and Efficacy of a Transvaginal Suture... | 临床试验