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HYbrid RObotic Surgery MulTiCentric Study
Sponsor: Rob Surgical Systems S.L.
Summary
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.
Official title: HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-01-15
Completion Date
2025-12
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
Radical Nephrectomy (RN)
Complete remove of the kidney. In addition as part of the intervention, a procedure termed "Lysis of abdominal adhesions" may be performed according to patient medical condition and/or surgeon criteria.
Partial nephrectomy (PN)
Partial remove of a section in the kidney. In addition, as part of the intervention, a procedure termed "Lysis of abdominal adhesions" may be performed according to patient medical condition and/or surgeon criteria.
Radical Prostatectomy (RP)
Complete remove of the prostate gland. In addition as part of the intervention, two procedures termed "Lysis of abdominal adhesions" and/or "Lymphadenectomy " (removal of regional lymph nodes) may be performed according to patient medical condition and/or surgeon criteria.
Locations (5)
Hospital del Mar
Barcelona, Spain, Spain
Hospital Clinic de Barcelona
Barcelona, Spain, Spain
Hospital General de Granollers
Granollers, Spain, Spain
Hospital de Mataró
Mataró, Spain, Spain
Hospital Universitari de Vic
Vic, Spain, Spain