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临床试验/NCT01197222
NCT01197222已完成不适用

Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

The Oregon Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1

研究概览

简要总结

Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

详细描述

The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.

Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>18 years of age
  • •Patients undergoing laparoscopic abdominal surgery

排除标准

  • •Patients with known coagulopathy or bleeding tendencies
  • •Intra-abdominal abscesses
  • •Non-elective laparoscopic surgery.

研究组 & 干预措施

EndoClear used

Active Comparator

The EndoClear device is used during a laparoscopic abdominal surgery.

干预措施: EndoClear Lens Cleaning Device (Device)

Control

No Intervention

EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.

研究者

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

Lee Swanstrom

MD

The Oregon Clinic

研究点 (1)

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