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RECRUITING
NCT06849271
NA

HYbrid RObotic Surgery MulTiCentric Study

Sponsor: Rob Surgical Systems S.L.

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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