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Completed

NCT Number: NCT05864040

HYbrid RObotic Surgery in Urology

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.

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Key information

Conditions

Nephrectomy Charcot-Marie-Tooth disease, Type 1C

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety of the Bitrack System

    Time frame: 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.

  2. Performance of the Bitrack System

    Time frame: 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 outcomes

  1. Number of Participants With Adverse Events

    Time frame: 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.

  2. Number of Participants With Absence of Tissue Damage

    Time frame: During the procedure

    Individual safety is defined as absence of unwanted injure of any tissue for each instrument.

  3. Individual Performance of Surgical Instruments

    Time frame: 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.

  4. Blood Loss

    Time frame: During the procedure

    Blood Loss defined as estimated mL of blood loss

  5. Transfusion Rates

    Time frame: During the procedure

    Transfusion rate as the number of participants that required blood transfusion

  6. Number of Participants That Require Hemostatic Agents.

    Time frame: During the procedure

    Number of participants that require the use of hemostatic agents.

  7. Operative Time Procedure

    Time frame: 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.

  8. Post-operative Pain

    Time frame: 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.

  9. Length of Stay (LoS) in Hospital

    Time frame: 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.

  10. Patient Pain Assessment

    Time frame: 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').

  11. Post-procedure Complication Rates - Comprehensive Complication Index (CCI)

    Time frame: 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).

  12. Post-procedure Complication Rates - Clavien-Dindo Classification

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rob Surgical Systems S.L.

Industry

Registry information

Official study title

HYROS (HYbrid RObotic Surgery in Urology)

Acronym: HYROS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 18, 2023
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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