Assessment of the Wide Field of View Provided by the SurroundScope
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of the need and potential benefits of the wide field of view
研究概览
简要总结
The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.
详细描述
The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope.
270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18
- •Capable of giving informed consent
- •Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System
排除标准
- •Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- •Patients with contraindications to undergo surgery
- •Patients with ASA class* >3
- •Advanced cirrhosis with failure of hepatic function
- •Patients who have participated in another interventional clinical study in the last month
- •Unable to consent (due to cultural, language or neurological barriers)
研究组 & 干预措施
SurroundScope
For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used
干预措施: SurroundScope (Device)
结局指标
主要结局
Assessment of the need and potential benefits of the wide field of view
时间窗: Day of surgery
Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree).
次要结局
- Assessment of the 270 Lenses clearance contribution to the procedure.(Day of surgery)
- A record of complications related to the SurroundScope(Day of surgery up to 2 weeks after the surgical procedure)