HYbrid RObotic Surgery MulTiCentric Study (NCT06849271) | Clinical Trial Compass
RecruitingNot Applicable
HYbrid RObotic Surgery MulTiCentric Study
Spain50 participantsStarted 2025-01-15
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.)
What they're measuring
1
Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries.