Safety and Performance Evaluation of the AutoLap System
2014年12月30日 更新者：M.S.T. Medical Surgery Technology LTD.
Safety and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the safety and performance of the AutoLap system in Laparoscopic Cholecystectomy procedures.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Signed and dated Informed Consent Form.
- Patients between 18 and 75 years of age inclusive who were scheduled for elective laparoscopic Cholecystectomy procedure.
Exclusion Criteria:
- Previous upper abdominal surgery and contraindications to Pneumoperitoneum.
- Pregnancy.
- Obesity (BMI >35 Kg/m2).
- Generalized peritonitis.
- Septic shock from cholangitis.
- Severe acute pancreatitis.
- Uncorrected coagulopathy.
- Previous abdominal operations which prevent safe abdominal access or progression of the procedure.
- Advanced cirrhosis with failure of hepatic function.
- Suspected gallbladder cancer.
- Acute cholecystitis
- Presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 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 |
|---|---|
|
实验性的：AutoLap
|
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 |
|---|---|---|
|
Adverse events
大体时间：participants will be followed for the duration of hospital stay, an expected average of 1-2 days
|
No conversion to open surgery from laparoscopic surgery due to using the AutoLap system 2) No AutoLap system related operative complications, that require further clinical intervention
|
participants will be followed for the duration of hospital stay, an expected average of 1-2 days
|
|
Performance evaluation
大体时间：during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
The ability of the AutoLap system to successfully move the laparoscope to the surgeon's desired position
|
during surgery -defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
system set-up time
大体时间：during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
defined as the time required from connecting the AutoLap's ARM to the bed rail
|
during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
|
Average total procedure time
大体时间：during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
defined as the time from first abdominal incision until the surgical procedure is completed
|
during surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
|
Number of times that the laparoscope was removed for cleaning
大体时间：During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
During surgery - defined as the time from the first abdominal incision until the surgical procedure is completed (skin incisions are closed).
|
|
|
Usability evaluation
大体时间：During surgery (at the end of the procedure)
|
the AutoLap system usability in laparoscopic procedures will be assessed by a questionnaire.
The questionnaire assesses the surgeon's satisfaction with the use of the AutoLap in regard to easiness of use, convenient of movement control and its ability to be used in the OR without interfering with the surgical flow
|
During surgery (at the end of the procedure)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2013年4月3日
首先提交符合 QC 标准的
2013年4月7日
首次发布 (估计)
2013年4月10日
研究记录更新
最后更新发布 (估计)
2014年12月31日
上次提交的符合 QC 标准的更新
2014年12月30日
最后验证
2014年12月1日
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.