HYbrid RObotic Surgery in Urology

NCT05864040 | Completed Results

• 1 other identifier: PL-PR01-027
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrectomy

Keywords

Radical; Simple; Laparoscopy

Outcome Measures

Primary Outcomes (2)

• Safety of the Bitrack System

  Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 30 days post-procedure period of enrolled patients indicated for robot assisted laparoscopic radical/simple nephrectomy. PRAEs are defined as any AE related to the investigational procedure.

  30 days post-procedure

• Performance of the Bitrack System

  Evaluation of the performance of the investigational device by means of its ability to access and reach the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to minimally invasive surgery (MIS) or open surgery. The performance of the Bitrack System and the ESE/NESE instruments is analyzed through the conversion rate to conventional laparoscopy/open surgery.

  During the procedure

Secondary Outcomes (12)

• Number of Participants With Adverse Events

  Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up

• Number of Participants With Absence of Tissue Damage

  During the procedure

• Individual Performance of Surgical Instruments

  During the procedure

• Blood Loss

  During the procedure

• Transfusion Rates

  During the procedure

Study Arms (1)

Subjects to undergo laparoscopic radical/simple nephrectomy

EXPERIMENTAL

Adult subjects between 18 and 90 years old, that provided informed consent prior to any clinical investigation-related procedure, who have been scheduled for a laparoscopic radical/simple nephrectomy surgery and who are able and willing to comply with all study requirements to be evaluated for each study visit.

Device: Bitrack System-assisted laparoscopic radical/simple nephrectomy

Interventions

Bitrack System-assisted laparoscopic radical/simple nephrectomy DEVICE

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.

Subjects to undergo laparoscopic radical/simple nephrectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects between 18 and 90 years old
• Subjects must provide written informed consent prior to any clinical investigation related procedure
• Subjects who have been scheduled for a laparoscopic radical/simple nephrectomy surgery
• Ability and willingness to comply with all study requirements to be evaluated for each study visit

You may not qualify if:

• Pregnant or breastfeeding women at the time of the surgery
• Inability to adhere to study-related procedures
• Subject has known allergy to some of the device components (i.e., stainless steel, etc.)
• Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow-up requirements
• Subjects not suitable to undergo MIS (Minimally Invasive Surgery) /MIRS (Minimally Invasive Robotic Surgery), according to medical criteria
• Subjects with life expectancy inferior to 3 months
• Subjects with a Body Mass Index (BMI) ≥ 40
• Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations
• Subjects with abuses of active substances or with uncontrolled psychiatric disorders
• Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system
• Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use

Sponsors & Collaborators

• Rob Surgical Systems S.L.: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Charcot-Marie-Tooth disease, Type 1C

Interventions

Nephrectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Jaume Amat, CEO
• Organization: Rob Surgical Systems

jaume.amat@robsurgical.com

+34 93 013 08 83

Study Officials

• Lluis Peri Cusi, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 18, 2023
• Study Start: April 11, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)