Finished
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
NCT06119568 · Rob Surgical Systems S.L. · Updated 20 July 2026
- What is being tested
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- For
- Nephrectomy; Prostatectomy
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years to 90 years. About 15 people. The full rules are on the registry page.
- Where
- Spain
- When
- Starts or started 1 Nov 2023, ends 29 April 2024. Registered 7 Nov 2023.
- Results
- Posted on the registry on 20 July 2026.
In the researchers' words
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.
Sites
- Hospital Clínic de BarcelonaBarcelona, Spain