HYbrid RObotic Surgery MulTiCentric Study

Launched by ROB SURGICAL SYSTEMS S.L. · Feb 24, 2025

Keywords

ClinConnect Summary

The HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I) is a clinical trial designed to test a new robotic surgery system called the ROB-Bitrack System. This study aims to see how effective this system is when used in surgeries for kidney and prostate conditions, specifically in procedures like kidney removal (nephrectomy) and prostate removal (prostatectomy). Researchers want to find out if the time it takes to complete these surgeries using the ROB-Bitrack System is equal to or less than the time taken with current standard methods, regardless of the surgeon's experience.

To participate in this study, individuals must be between 18 and 90 years old and scheduled for one of the targeted surgeries. They should also be able to follow the study's guidelines and provide written consent. However, those who are pregnant, have certain health conditions, or cannot undergo minimally invasive surgery are not eligible. Participants can expect to be monitored for 30 days after their surgery to gather data on their recovery and any effects of the robotic system. This study is currently recruiting participants, and it seeks to provide valuable information on the safety and efficiency of advanced robotic surgical techniques.

Gender

ALL

Eligibility criteria

• 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 PrincipaI investigator´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 Minimally Invasive Surgery (MIS)/ Minimally Invasive Robotic Surgery (MIRS), according to medical criteria.
• • 7. Subjects with life expectancy inferior to 3 months.
• • 8. Subjects with a BMI (Body Mass Index) ≥ 40
• • 9. Subjects with any contraindication for the use of the ROB-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