NCT01823055已完成不适用
Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
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
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
Daniel Altman
Md, PhD, Associate professor
Karolinska Institutet
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