HYROS (HYbrid RObotic Surgery in Urology)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Safety of the Bitrack System
研究概览
简要总结
The HYbrid RObotic Surgery in urology (HYROS) study is an early feasibility clinical investigation of a new medical device under the commercial name of Bitrack System. Bitrack System is a surgical robot indicated to be used during urological surgical procedures. The Bitrack System also requires the specific single use of Electro-Surgical Endoscopic (ESE) instruments and Non-Electro Surgical Endoscopic (NESE) instruments.
The purpose of this clinical investigation is to evaluate the safety and feasibility of the Bitrack System and its corresponding ESE and NESE instruments in patients with the indication of a robot assisted laparoscopic radical/simple nephrectomy.
详细描述
The Bitrack System is a surgical robot indicated to be used during urological surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.
Robotic Assisted Surgical (RAS) systems and equipment such as Bitrack System are intended for use in invasive surgical procedures, during which patients are potentially most vulnerable to physical harm. The Bitrack System comprises a console, a robotic unit, and embedded software.
The HYROS clinical investigation will be conducted as a single-center, early feasibility, and first-in-human (FIH) clinical investigation with a single arm, open-label, and non-randomized design, that will include 3 patients. This clinical investigation aims to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical/simple nephrectomy surgery.
The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days Follow-up visit, and 30-Days Follow-up visit (remote). The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic radical/simple nephrectomy. The total duration of the clinical investigation is expected to be 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects between 18 and 90 years old
- •Subjects must provide written informed consent prior to any clinical investigation related procedure
- •Subjects who have been scheduled for a laparoscopic radical/simple nephrectomy surgery
- •Ability and willingness to comply with all study requirements to be evaluated for each study visit
排除标准
- •Pregnant or breastfeeding women at the time of the surgery
- •Inability to adhere to study-related procedures
- •Subject has known allergy to some of the device components (i.e., stainless steel, etc.)
- •Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow-up requirements
- •Subjects not suitable to undergo MIS (Minimally Invasive Surgery) /MIRS (Minimally Invasive Robotic Surgery), according to medical criteria
- •Subjects with life expectancy inferior to 3 months
- •Subjects with a Body Mass Index (BMI) ≥ 40
- •Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations
- •Subjects with abuses of active substances or with uncontrolled psychiatric disorders
- •Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system
- •Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use
结局指标
主要结局
Safety of the Bitrack System
时间窗: 30 days post-procedure
Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 30 days post-procedure period of enrolled patients indicated for robot assisted laparoscopic radical/simple nephrectomy. PRAEs are defined as any AE related to the investigational procedure.
Performance of the Bitrack System
时间窗: During the procedure
Evaluation of the performance of the investigational device by means of its ability to access and reach the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to minimally invasive surgery (MIS) or open surgery. The performance of the Bitrack System and the ESE/NESE instruments is analyzed through the conversion rate to conventional laparoscopy/open surgery.
次要结局
- Number of Participants With Adverse Events(Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up)
- Number of Participants With Absence of Tissue Damage(During the procedure)
- Individual Performance of Surgical Instruments(During the procedure)
- Blood Loss(During the procedure)
- Transfusion Rates(During the procedure)
- Number of Participants That Require Hemostatic Agents.(During the procedure)
- Operative Time Procedure(During the entire surgical procedure)
- Post-operative Pain(Day 1 and Day 2 post-procedure)
- Length of Stay (LoS) in Hospital(Discharge (up to one week post-procedure))
- Patient Pain Assessment(Discharge (up to one week post-procedure), 14- and 30-days post-procedure)
- Post-procedure Complication Rates - Comprehensive Complication Index (CCI)(Discharge (up to one week post-procedure),14 and 30 days follow-up)
- Post-procedure Complication Rates - Clavien-Dindo Classification(Discharge (up to one week post-procedure),14 and 30 days follow-up)