NCT05864040

HYbrid RObotic Surgery in Urology

HYROS (HYbrid RObotic Surgery in Urology)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Rob Surgical Systems S.L. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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. The Bitrack System also requires the specific single use of Electro-Surgical Endoscopic (ESE) instruments and Non-Electro Surgical Endoscopic (NESE) 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 in patients with the indication of a robot assisted laparoscopic radical/simple nephrectomy.

Detailed description

The Bitrack System is a surgical robot indicated to be used during urological 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 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 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.

Conditions

• Nephrectomy

Interventions

Type	Name	Description
DEVICE	Bitrack System-assisted laparoscopic radical/simple nephrectomy	Robot-Assisted Laparoscopic Transperitoneal Radical/Simple Nephrectomy is performed under general anesthesia. Using blunt dissection, the inferior pole of the kidney is lifted, and ureter and gonadal veins released from fat and connective tissue. The ureter is dissected caudally and sectioned after being sealed with a distal endoscopic clip. Dissection proceeds along the psoas muscle with anterior elevation of the ureter and lower renal pole towards the hilium. Main hilar are circumferentially dissected and sectioned and the kidney is entirely mobilized and released. Gerota´s capsule and suprarenal gland may be preserved if oncologically safe. Once the specimen is completely released, a laparoscopic bag is introduced by the assistant and the specimen entrapped. The robot is undocked, gas evacuated from the abdomen and specimen retrieved.

Timeline

• Start date: 2023-04-11
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2023-05-18
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

1 site across 1 country: Spain