HYbrid RObotic Surgery in Urology

Not Applicable

Completed

Conditions: Nephrectomy

Registration Number: NCT05864040

Lead Sponsor: Rob Surgical Systems S.L.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of the Bitrack System	30 days post-procedure	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.
Performance of the Bitrack System	During the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Length of Stay (LoS) in Hospital	Discharge (up to one week post-procedure)	Assessment of the duration of subject's hospitalization as the Length of Stay (LoS) in hospital calculated from day of admission to day of discharge.
Patient Pain Assessment	Discharge (up to one week post-procedure), 14- and 30-days post-procedure	Patient pain assessment via Visual Analog Score (VAS) for pain on a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').
Post-procedure Complication Rates - Comprehensive Complication Index (CCI)	Discharge (up to one week post-procedure),14 and 30 days follow-up	Post-procedure complication rates assessment by measuring the Comprehensive Complication Index (CCI) on a scale from 0 (no complications) to 100 (death).
Post-procedure Complication Rates - Clavien-Dindo Classification	Discharge (up to one week post-procedure),14 and 30 days follow-up	Post-procedure complication rates assessment by the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, Iva, Ivb and V), the first one (I) indicating any deviation from the normal postoperative course and the highest (V) corresponding to death.
Number of Participants With Adverse Events	Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up	All AE(s) events during the procedure and through the 14 and 30 days post-procedure were also assessed, including the assessment of the relationship with the investigational device and/or procedure by the principal investigator.
Number of Participants With Absence of Tissue Damage	During the procedure	Individual safety is defined as absence of unwanted injure of any tissue for each instrument.
Individual Performance of Surgical Instruments	During the procedure	Individual performance is assessed by the Visual Analogue Scale (ranging from 0 to 10) following the subjective surgeon's opinion for each instrument surgical function, being 0 a non-functional tool and 10 an instrument that works exactly equivalent to the surgeon/s hands.
Blood Loss	During the procedure	Blood Loss defined as estimated mL of blood loss
Transfusion Rates	During the procedure	Transfusion rate as the number of participants that required blood transfusion
Number of Participants That Require Hemostatic Agents.	During the procedure	Number of participants that require the use of hemostatic agents.
Operative Time Procedure	During the entire surgical procedure	Operative Time Procedure (or Surgical Procedure Time) includes the time spend to perform the set of all the different tasks completed during the surgical procedure. It is defined from first ESE/NESE instruments docking to the conversion to gestural mode for their final withdrawal.
Post-operative Pain	Day 1 and Day 2 post-procedure	Evaluation of the post-operative pain in patients through the Cumulative Analgesic Consumption Score (CACS) during the first week (7days) post-procedure. To calculate the CACS score, information on the number of single analgesic doses (n) and their classification on the WHO pain relief ladder was collected. The WHO pain relief ladder ranges from I to III: * step I (nonopioids): acetaminophen, ibuprofen or metamizole; * step II (opioids for mild to moderate pain): tramadol, tilidine/naloxone; * step III (opioids for moderate to severe pain): piritramide, pethidine, oxycodone or morphine. The Cumulative Analgesic Consumption Score (CACS) is calculated by adding all (n), multiplied by the level of the WHO pain relief ladder. Since the lenght of stay was shorter (2-3 days), it was not possible to collect the analgesic consumption up to 7 days after patient hospital discharge.