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Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
Sponsor: Rob Surgical Systems S.L.
Summary
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.
Official title: HYbrid RObotic Surgery in Partial, Radical Nephrectomy and Prostatectomy (HYROS-PRnP)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2023-11-01
Completion Date
2024-04-29
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
Locations (1)
Hospital Clínic de Barcelona
Barcelona, Spain