New Use of the ViKY Device for Uterus Positioning
Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
研究概览
详细说明
The ViKY device "Vision Control for endoscopy" was initially a compact motorized endoscope holder for laparoscopic surgery. It holds the endoscope and is controlled by either a foot pedal or voice activation. It received FDA approval in December 2008 and since that time has been used to facilitate laparoscopic surgery in multiple specialties.
EndoControl now considers using the technology for uterus manipulation in laparoscopic-assisted hysterectomies. Most gynecologic surgeries require displacement of the uterus out of the anatomic location to optimize the surgery. During an abdominal hysterectomy clamps are placed on the uterine cornua allowing easy manipulation of the uterus. The development of laparoscopic surgery required new techniques to manipulate the uterus. Typically a uterine manipulator is placed vaginally and controlled by the surgeon or the surgical assistant during the procedure.
In conventional operations, the constant physical force decreases the surgical team's efficacy and increases fatigue levels. The use of the ViKY device to control the position of the uterus facilitates surgery by enabling the surgeon to maintain a constant "locked" position or by allowing the surgeon to remotely move the uterus at any point of the surgery. The ViKY device also eliminates the need for an extra surgical assistant during laparoscopic-assisted hysterectomies.
The aim of this study is to collect data to demonstrate safety and effectiveness of the use of the ViKY device for uterine manipulation during conventional laparoscopic-assisted hysterectomies or computer-controlled laparoscopic hysterectomies.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Florida
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Orlando、Florida、美国、32804
- Florida Hospital
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North Carolina
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Charlotte、North Carolina、美国、28203
- Carolinas Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-80
- Candidate for conventional laparoscopic-assisted hysterectomies procedures
- patient has a cervix and a uterus
Exclusion criteria
- Difficulty understanding the English language
- Anatomy that precludes the use of a uterine manipulator
- Current inclusion in another research study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Hysterectomy
candidate for a conventional laparoscopic-assisted
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laparoscopic-assisted hysterectomy procedure
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Effectiveness
大体时间:4 months
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Number of cases with adequate visualization of pelvic anatomy during endoscopy.
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4 months
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Adverse Events
大体时间:4 months
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Number of perforations during intervention.
Number of complications associated with the use of uterine manipulator
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
surgery characterization
大体时间:4 months
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Duration of time of each procedure, duration of time to set up Viky UP device
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4 months
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合作者和调查者
赞助
调查人员
- 首席研究员:Arnold ADVINCULA, MD、Floridal Hospital
- 首席研究员:Kevin STEPP, MD、Carolinas Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
ViKY UP的临床试验
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Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)主动,不招人
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research Center; Oregon Research Institute 和其他合作者招聘中
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)主动,不招人
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Oregon Health and Science UniversityTexas A&M University; University of North Carolina, Greensboro主动,不招人
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Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre Copenhagen完全的
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Universidad Complutense de MadridUniversity of Alcala; Ministerio de Economía y Competitividad, Spain; Council of Madrid终止