HYbrid RObotic Surgery MulTiCentric Study

Last updated: June 3, 2026
Sponsor: Rob Surgical Systems S.L.
Overall Status: Completed

Phase

N/A

Condition

Prostate Disorders

Treatment

Radical Nephrectomy (RN)

Radical Prostatectomy (RP)

Partial nephrectomy (PN)

Clinical Study ID

NCT06849271
PL-PR01-150
  • Ages 18-90
  • All Genders

Study Summary

The purpose of this clinical investigation, HYROS-MTC-I, is to confirm the effectiveness of the combined use of ROB-Bitrack System, its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in a multicentric study in urologic procedures with the indication of a robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN), Radical Prostatectomy (RP or P), and when it applies Lysis of Adhesions (during a PN, RN or RP or P to cut the adhesions and reach the organ) and Lymphadenectomy (only after a P with the aim to remove the lymph nodes) . HYROS-MTC-I is a confirmatory study in which the hypothesis of the primary endpoint is that: "Operative time (OT) with Bitrack System and its ESE/NESE Instruments and accessories will be equal or lower than superiority margin time of State of the Art (SoTA) of MIRS (Minimally Invasive Robotic Surgery) independently of the user experience and site". This study includes the data collected up to 30 days post-surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult subjects between 18 and 90 years old who have provided written informedconsent prior to any clinical investigation related procedures.

  2. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomysurgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomyfollowing the surgeon criteria.

  3. Ability and willingness to comply with all study requirements to be evaluated foreach study visit.

Exclusion

Exclusion Criteria:

  1. Pregnant or breastfeeding women at the time of the surgery.

  2. Subjects with severe concomitant illness that, at PrincipaI investigator´sdiscretion, increases risk of therapeutic interventions or that have been submittedto multiple prior surgeries.

  3. Subjects admitted to the hospital due to an emergency situation.

  4. Subjects with untreated active infection.

  5. Subject with known allergy to some of the device components (i.e., stainless steel,etc.)

  6. Subjects not suitable to undergo Minimally Invasive Surgery (MIS)/ MinimallyInvasive Robotic Surgery (MIRS), according to medical criteria.

  7. Subjects with life expectancy inferior to 3 months.

  8. Subjects with a BMI (Body Mass Index) ≥ 40

  9. Subjects with any contraindication for the use of the ROB-Bitrack System and theESE/NESE instruments, as specified in the Instructions For Use.

  10. Subjects with abuses of active substances or with uncontrolled psychiatricdisorders.

  11. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disordersor that have been submitted to multiple prior operations.

  12. Subjects scheduled for surgeries intended to be in direct contact with the heart,the central circulatory system or the central nervous system.

  13. Inability to adhere to study-related procedures.

  14. Subjects who participate in another trial which may affect the outcome data on thisstudy or the ability to complete the follow up requirements

Study Design

Total Participants: 27
Treatment Group(s): 3
Primary Treatment: Radical Nephrectomy (RN)
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
November 26, 2025

Study Description

The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-MTC-I clinical investigation will be conducted as a multi-center, with a single arm, open-label, and non-randomized design, that will include 50 patients. The study shall refer to effectiveness of ROB-Bitrack System together with its accessories and corresponding ESE/NESE instruments. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days and 30-Days Follow-up visit . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic Radical Nephrectomy, Partial Nephrectomy or Radical Prostatectomy. The expected duration of the study is 12 months from the first patient enrolled, including 11 months of enrollment and the follow up of 30 days after surgery. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.

Connect with a study center

  • Hospital Clinic de Barcelona

    Barcelona, Spain 08036
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, Spain 08003
    Spain

    Site Not Available

  • Hospital General de Granollers

    Granollers, Spain 08402
    Spain

    Site Not Available

  • Hospital de Mataró

    Mataró, Spain 08304
    Spain

    Site Not Available

  • Hospital Universitari de Vic

    Vic, Spain 08500
    Spain

    Site Not Available

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