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临床试验/NCT01953627
NCT01953627Unknown不适用

Laparoscopic Gynecologic Surgery With Robotic Assistance System Kymerax® : Pilot Study

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
assessment of Kymerax systemerax

研究概览

简要总结

Laparoscopic robotic surgery (LSM) seems to increase quality of surgery. Diffusion of LSM is limited by cots of the only available system today. Kymerax® is a cheaper new system of LSM.

Aim : To evaluate feasibility of laparoscopy with Kymerax® system in different laparoscopic procedures in gynecology.

Material and methods : Observational study. Inclusion criteria were : patient requiring laparoscopic procedure in gynecology who give informed consent. The investigators evaluate procedures routinely performed by laparoscopy in gynecology.

Hypothesis : Procedures performed routinely in gynecology were feasible with Kymerax® system.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient requiring a following surgical procedure realized usually by coelioscopy:
  • Total hysterectomy or inter annexielle for mild or neoplastic pathology Promontofixation for genital prolapse Annexectomie or ovarian kystectomie for ovarian pathology Pelvic or lombo-aortic cleaning out for uterine cancer Tubaire Salpingectomie for pathology Rectovaginale partition Exérèse hurts of endometriosis

排除标准

  • Patient refusing to participate in the study
  • Patient understanding French.
  • Minor waits

结局指标

主要结局

assessment of Kymerax systemerax

时间窗: 18 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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