Assessment of the SurroundScope in Urologic Surgical Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery
研究概览
简要总结
The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope
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 compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients are not aware of the laparoscopic system that will be used during the operation.
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 laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy
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 laparoscopic surgery.
- •Patients with American Society of Anesthesiology (ASA) class* >3
- •Advanced cirrhosis with failure of hepatic function
- •Patients who have participated in another interventional clinical study in the last month.
- •Pregnancy
- •Unable to consent (due to cultural, language or neurological barriers)
结局指标
主要结局
Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery
时间窗: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - skin to skin time of surgery
Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time
时间窗: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - Visibility time of tools and ports in the Field of view
Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals
时间窗: During the surgery - Since the first incision performed till the last incision is closed
Data collected include - Time of scope removals during the case to clear smoke or fog
次要结局
- Time of defined surgical tasks - clamp time(During the defined surgical task)
- Time of defined surgical tasks - port placement time(During the defined surgical task)
- Time of defined surgical tasks - transection time(During the defined surgical task)