Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
NCT: NCT06119568 · COMPLETED
Brief 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.
Frequently Asked Questions
What is Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP?
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP is a clinical trial registered under NCT06119568. Current status: COMPLETED.
What is the status of NCT06119568?
The current status of NCT06119568 (Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP) is: COMPLETED.
When did Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP start?
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP started on 2023-11-01.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.