HYbrid RObotic Surgery in Urology

Study Overview
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Brief Summary
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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, general abdominal laparoscopic surgical procedures, and gynecological laparoscopic surgical procedures. The Bitrack System also requires the specific single use of endoscopic (both electrosurgical -ESE- and non-electrosurgical -NESE-) surgical 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 and accessories in patients with the indication of a robot assisted laparoscopic radical/simple nephrectomy. Additionally, this investigation will collect initial clinical evidence for the process of obtaining CE Mark

Detailed Description
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The Bitrack System is a surgical robot indicated to be used during urological surgical procedures, general abdominal laparoscopic surgical procedures, and gynecological laparoscopic 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 clinical benefits of the use of the Bitrack System include the minimization of trauma and tearing around the incision thanks to passive joints in robotic arms that allow to avoidance of the stress forces in the fulcrum point that can damage the tissues. 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 data gathered in this study will be used to support the initial stages of clinical evidence collection for CE Mark of the Bitrack System. The data collected in this study will be used to design additional clinical investigations using an appropriately powered sample size to enable further assessment of the study safety and performance endpoints of the Bitrack System in the intended populations. 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.

Official Title
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HYROS (HYbrid RObotic Surgery in Urology)

Conditions
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Nephrectomy

Intervention / Treatment
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* Device: Bitrack System-assisted laparoscopic radical/simple nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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/MIRS, according to medical criteria Subjects with life expectancy inferior to 3 months Subjects with a 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects to undergo laparoscopic radical/simple nephrectomy<br>Adult subjects between 18 and 90 years old, that provided informed consent prior to any clinical investigation-related procedure, who have been scheduled for a laparoscopic radical/simple nephrectomy surgery and who are able and willing to comply with all study requirements to be evaluated for each study visit. | Device: Bitrack System-assisted laparoscopic radical/simple nephrectomy<br>* Robot-Assisted Laparoscopic Transperitoneal Radical/Simple Nephrectomy is performed under general anesthesia. Using blunt dissection, the inferior pole of the kidney is lifted, and ureter and gonadal veins released from fat and connective tissue. The ureter is dissected caudally and sectioned after being sealed with a distal endoscopic clip. Dissection proceeds along the psoas muscle with anterior elevation of the ureter and lower renal pole towards the hilium. Main hilar are circumferentially dissected and sectioned and the kidney is entirely mobilized and released. Gerota´s capsule and suprarenal gland may be preserved if oncologically safe. Once the specimen is completely released, a laparoscopic bag is introduced by the assistant and the specimen entrapped. The robot is undocked, gas evacuated from the abdomen and specimen retrieved. Abdominal wall incisions over 10mm are closed using a continuous suture. Skin incisions are closed using skin staplers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Bitrack System | 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 | 30 days post-procedure | 
| Performance of the Bitrack System | Evaluation of the performance of the investigational devices 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 MIS or open surgery. The performance of the Bitrack System and the ESE/NESE instruments will be analyzed through the conversion rate to conventional laparoscopy/open surgery | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs | All AE(s) events during the procedure and through the 30 days postprocedure will also be assessed, and therefore relationship with the investigational device and/or procedure will be examined by the principal investigator. | Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up | 
| Number of participants without unwanted injure of any tissue | Individual safety (i.e., absence of unwanted injure of any tissue) for each instrument surgical function. | During the rocedure | 
| Individual performance | Individual performance (VAS scale 0-10 following the subjective surgeon's opinion, being 0 a non-functional tool and 10 an instrument that works exactly equivalent to the surgeon/s hands) for each instrument surgical function. | During the procedure | 
| Blood Loss | Blood Loss defined as estimated mL of blood loss | During the procedure | 
| Transfusion rates | Transfusion rates | During the procedure | 
| Number of participants that require hemostatic agents. | Number of participants that require the use of hemostatic agents. | During the procedure | 
| Operative Time Procedure | Operative Time Procedure measurement for the different tasks. | During the procedure | 
| Post-operative pain | Evaluation of the post-operative pain in patients through the Cumulative Analgesic Consumption Score (CACS) during the first week (7days) post-procedure | Discharge (up to one week post-procedure) | 
| Length of Stay (LoS) in hospital | Assessment of the duration of subject's hospitalization as the Length of Stay (LoS) in hospital calculated from day of admission to day of discharge. | Discharge (up to one week post-procedure) | 
| Patient pain assessment | Patient pain assessment via VAS (Visual Analog Score for pain) on a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be') . | Discharge (up to one week post-procedure) , 14- and 30-days post-procedure | 
| Post-procedure complication rates - comprehensive complication index (CCI) | Post-procedure complication rates assessment by measuring the comprehensive complication index (CCI) on a scale from 0 (no complications) to 100 (death). | Discharge (up to one week post-procedure),14 and 30 days follow-up | 
| Post-procedure complication rates - Clavien-Dindo classification | Post-procedure complication rates assessment by the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, Iva, Ivb and V, with V corresponding to death). | Discharge (up to one week post-procedure),14 and 30 days follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical, Simple, Laparoscopy