HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)

June 3, 2026 updated by: Rob Surgical Systems S.L.

HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Spain
      • Barcelona, Spain, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, Spain, 08003
        • Hospital del Mar
      • Granollers, Spain, Spain, 08402
        • Hospital General de Granollers
      • Mataró, Spain, Spain, 08304
        • Hospital de Mataró
      • Vic, Spain, Spain, 08500
        • Hospital Universitari de Vic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures.
  2. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
  3. Ability and willingness to comply with all study requirements to be evaluated for each study visit.

Exclusion Criteria:

  1. Pregnant or breastfeeding women at the time of the surgery.
  2. Subjects with severe concomitant illness that, at PrincipaI investigator´s discretion, increases risk of therapeutic interventions or that have been submitted to 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)/ Minimally Invasive 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 the ESE/NESE instruments, as specified in the Instructions For Use.
  10. Subjects with abuses of active substances or with uncontrolled psychiatric disorders.
  11. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or 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 this study or the ability to complete the follow up requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories
Procedure: Radical Nephrectomy (RN)
Complete remove of the kidney. In addition as part of the intervention, a procedure termed "Lysis of abdominal adhesions" may be performed according to patient medical condition and/or surgeon criteria.
Procedure: Partial nephrectomy (PN)
Partial remove of a section in the kidney. In addition, as part of the intervention, a procedure termed "Lysis of abdominal adhesions" may be performed according to patient medical condition and/or surgeon criteria.
Procedure: Radical Prostatectomy (RP)
Complete remove of the prostate gland. In addition as part of the intervention, two procedures termed "Lysis of abdominal adhesions" and/or "Lymphadenectomy " (removal of regional lymph nodes) may be performed according to patient medical condition and/or surgeon criteria.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries.
Time Frame: During the procedure
Evaluation of Operative time from first skin incision to last skin suture of the procedure.It is hypothesized that Operative time (OT) will be equal or lower than the maximum time as defined by the State of the Art (SoTA) of MIRS independently of the user experience and site.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rob Surgical Systems S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PL-PR01-150

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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