NCT06119568

Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP

HYbrid RObotic Surgery in Partial, Radical Nephrectomy and Prostatectomy (HYROS-PRnP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rob Surgical Systems S.L. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation is 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. HYROS-PRnP is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by Bitrack System which operates exclusively under surgeon's orders. The study shall refer to safety and performance of Bitrack System together with its accessories and corresponding ESE/NESE instruments. This study includes the data collected up to 30 days post-surgery and provides the evidence that the tested medical devices fulfill the GSPR.

Detailed description

The Bitrack System is first 4-arms on demand open robotic platform indicated to be used during general abdominal laparoscopic urologic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation. The HYROS-PRnP clinical investigation will be conducted as a single-center, with a single arm, open-label, and non-randomized design, that will include 15 patients. This clinical investigation aims to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical nephrectomy, Partial nephrectomy or Radical Prostatectomy surgeries. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days Follow-up visit, and 30-Days Follow-up visit (remote). The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic Radical Nephrectomy. Partial Nephrectomy or Radical Prostatectomy. The total duration of the clinical investigation is expected to be 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.

Conditions

• Nephrectomy
• Prostatectomy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-01
• Completion: 2024-04-29
• First posted: 2023-11-07
• Last updated: 2024-05-29

Locations

1 site across 1 country: Spain