HYbrid RObotic Surgery in Urology — HYROS  

Nephrectomy Clinical Trial

Official title: HYROS (HYbrid RObotic Surgery in Urology)

Status Recruiting

Clinical Trial Summary

The HYbrid RObotic Surgery in urology (HYROS) study is an early feasibility clinical investigation of a new medical device under the commercial name of Bitrack System. Bitrack System is a surgical robot indicated to be used during urological surgical procedures, general abdominal laparoscopic surgical procedures, and gynecological laparoscopic surgical procedures. The Bitrack System also requires the specific single use of endoscopic (both electrosurgical -ESE- and non-electrosurgical -NESE-) surgical instruments.

The purpose of this clinical investigation is to evaluate the safety and feasibility of the Bitrack System and its corresponding ESE and NESE instruments and accessories in patients with the indication of a robot assisted laparoscopic radical/simple nephrectomy. Additionally, this investigation will collect initial clinical evidence for the process of obtaining CE Mark

Clinical Trial Description

The Bitrack System is a surgical robot indicated to be used during urological surgical procedures, general abdominal laparoscopic surgical procedures, and gynecological laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.

Robotic Assisted Surgical (RAS) systems and equipment such as Bitrack System are intended for use in invasive surgical procedures, during which patients are potentially most vulnerable to physical harm. The clinical benefits of the use of the Bitrack System include the minimization of trauma and tearing around the incision thanks to passive joints in robotic arms that allow to avoidance of the stress forces in the fulcrum point that can damage the tissues. The Bitrack System comprises a console, a robotic unit, and embedded software.

The HYROS clinical investigation will be conducted as a single-center, early feasibility, and first-in-human (FIH) clinical investigation with a single arm, open-label, and non-randomized design, that will include 3 patients. This clinical investigation aims to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical/simple nephrectomy surgery. The data gathered in this study will be used to support the initial stages of clinical evidence collection for CE Mark of the Bitrack System. The data collected in this study will be used to design additional clinical investigations using an appropriately powered sample size to enable further assessment of the study safety and performance endpoints of the Bitrack System in the intended populations.

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/simple nephrectomy. 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. ;

Related Conditions & MeSH terms

• Nephrectomy

• NCT number: NCT05864040
• Study type: Interventional
• Source: Rob Surgical Systems S.L.
• Contact: Jaume Amat
• Phone: +34 93 013 08 83
• Email: jaume.amat@robsurgical.com
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Completion date: June 20, 2023