Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP

The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of a robot assisted laparoscopic Radical Nephrectomy (RN), Partial Nephrectomy (PN) or Radical Prostatectomy (RP), as applicable.The HYROS-PRnP study served as a confirmatory investigation, with the primary endpoint hypothesis centered around the effective performance of the Bitrack System and the ESE/NESE instruments and accessories as intended by the surgeon during the intervention.This study included the data collected up to 30 days post-surgery and provided the evidence that the tested medical devices fulfill the GSPR.

Inclusion Criteria: 1. Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures. 2. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria. 3. Ability and willingness to comply with all study requirements to be evaluated for each study visit. Exclusion Criteria: 1. Pregnant or breastfeeding women at the time of the surgery. 2. Subjects with severe concomitant illness that, at PI´s discretion, increases risk of therapeutic interventions or that have been submitted to multiple prior surgeries. 3. Subjects admitted to the hospital due to an emergency situation. 4. Subjects with untreated active infection. 5. Subject with known allergy to some of the device components (i.e., stainless steel, etc.) 6. Subjects not suitable to undergo MIS/MIRS, according to medical criteria. 7. Subjects with life expectancy inferior to 3 months. 8. Subjects with a BMI ≥ 40. 9. Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use. 10. Subjects with abuses of active substances or with uncontrolled psychiatric disorders. 11. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations. 12. Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system. 13. Inability to adhere to study-related procedures. 14. Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements.