HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries.
研究概览
简要总结
The purpose of this clinical investigation, HYROS-MTC-I, is to confirm the effectiveness of the combined use of ROB-Bitrack System, its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in a multicentric study in urologic procedures with the indication of a robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN), Radical Prostatectomy (RP or P), and when it applies Lysis of Adhesions (during a PN, RN or RP or P to cut the adhesions and reach the organ) and Lymphadenectomy (only after a P with the aim to remove the lymph nodes) . HYROS-MTC-I is a confirmatory study in which the hypothesis of the primary endpoint is that: "Operative time (OT) with Bitrack System and its ESE/NESE Instruments and accessories will be equal or lower than superiority margin time of State of the Art (SoTA) of MIRS (Minimally Invasive Robotic Surgery) independently of the user experience and site". This study includes the data collected up to 30 days post-surgery.
详细描述
The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-MTC-I clinical investigation will be conducted as a multi-center, with a single arm, open-label, and non-randomized design, that will include 50 patients. The study shall refer to effectiveness of ROB-Bitrack System together with its accessories and corresponding ESE/NESE instruments. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days and 30-Days Follow-up visit . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic Radical Nephrectomy, Partial Nephrectomy or Radical Prostatectomy. The expected duration of the study is 12 months from the first patient enrolled, including 11 months of enrollment and the follow up of 30 days after surgery. 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
- Treatment
- 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 who have provided written informed consent prior to any clinical investigation related procedures.
- •Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
- •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.
- •Subjects with severe concomitant illness that, at PrincipaI investigator´s discretion, increases risk of therapeutic interventions or that have been submitted to multiple prior surgeries.
- •Subjects admitted to the hospital due to an emergency situation.
- •Subjects with untreated active infection.
- •Subject with known allergy to some of the device components (i.e., stainless steel, etc.)
- •Subjects not suitable to undergo Minimally Invasive Surgery (MIS)/ Minimally Invasive Robotic Surgery (MIRS), according to medical criteria.
- •Subjects with life expectancy inferior to 3 months.
- •Subjects with a BMI (Body Mass Index) ≥ 40
- •Subjects with any contraindication for the use of the ROB-Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use.
- •Subjects with abuses of active substances or with uncontrolled psychiatric disorders.
- •Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations.
- •Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system.
- •Inability to adhere to study-related procedures.
- •Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements
研究组 & 干预措施
Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories
干预措施: Radical Nephrectomy (RN) (Procedure)
Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories
干预措施: Partial nephrectomy (PN) (Procedure)
Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories
干预措施: Radical Prostatectomy (RP) (Procedure)
结局指标
主要结局
Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries.
时间窗: During the procedure
Evaluation of Operative time from first skin incision to last skin suture of the procedure.It is hypothesized that Operative time (OT) will be equal or lower than the maximum time as defined by the State of the Art (SoTA) of MIRS independently of the user experience and site.
次要结局
未报告次要终点