NCT01534832已完成1 期
Assessment of a New Surgical Smoke Clearing Technology, "Innervision", in Laparoscopic Cholecystectomy
Asalus Medical Instruments Limited2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maintenance of a clear visual field during surgery
研究概览
简要总结
The study will examine the safety and performance of a new surgical smoke clearance system designed for use during laparoscopic surgery.
详细描述
The study will examine the safety and performance of a new surgical smoke clearance system which has been developed to maintain a visually clear operative field during laparoscopic surgery by using electrostatic precipitation to clear, from the surgical field, smoke and plume produced by energy based surgical instruments e.g. electrocautery, laser tissue ablation and ultrasonic scalpel tissue dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age
- •Undergoing elective laparoscopic cholecystectomy for documented symptomatic gallstone disease
- •Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
排除标准
- •<18 years of age
- •Pregnant or lactating females
- •Previous extensive abdominal surgery, which in the opinion of the Investigator presents a >5% risk of conversion to an open procedure being required
- •Current participation in another device or drug study
- •Unwilling or unable to provide informed consent
结局指标
主要结局
Maintenance of a clear visual field during surgery
时间窗: 3m
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating RoomsSmokeNCT02672969Mahidol University128
已完成
不适用
Reducing the Negative Effects of Surgical Conditions Use of Double Layer Mask Against Electrocautery With Smoke FilterSurgical Procedure, UnspecifiedNCT06550492Ataturk University108
已完成
2 期
Safety and Feasibility Study of a Mechanical Ventilation Computerized Protocol: IntelliventMechanical Ventilation Weaning Phase in ChildrenNCT01095406St. Justine's Hospital19
尚未招募
不适用
Evaluation of Noxious Chemicals in Surgical Smoke and Efficacy of a Smoke EvacuatorGastrointestinal disease which needs laparotomyJPRN-UMIN000044250The University of Tokyo42
招募中
2 期
Environmental research using a surgical smoke evacuation system in an operation roomBreast cancerJPRN-UMIN000029092Tokai University School of Medicine Department of Breast and Endocrine Surgery100