NephrectomyHYROS-MTC-INCT06849271
HYbrid RObotic Surgery MulTiCentric Study
A study testing Radical Nephrectomy (RN), Partial nephrectomy (PN) and Radical Prostatectomy (RP) in people with Nephrectomy and Prostatectomy, run by Rob Surgical Systems S.L. at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nephrectomy, Prostatectomy
- What is being tested?
- Radical Nephrectomy (RN), Partial nephrectomy (PN) and Radical Prostatectomy (RP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 5 sitesSpain
- Study dates
- 15 Jan 2025to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures.
- Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
- Ability and willingness to comply with all study requirements to be evaluated for each study visit.
Who cannot join
- Pregnant or breastfeeding women at the time of the surgery.
- 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.
- Subjects admitted to the hospital due to an emergency situation.
- Subjects with untreated active infection.
- Subject with known allergy to some of the device components (i.e., stainless steel, etc.)
- Subjects not suitable to undergo Minimally Invasive Surgery (MIS)/ Minimally Invasive Robotic Surgery (MIRS), according to medical criteria.
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- Subjects with life expectancy inferior to 3 months.
- Subjects with a BMI (Body Mass Index) ≥ 40
- Subjects with any contraindication for the use of the ROB-Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use.
- Subjects with abuses of active substances or with uncontrolled psychiatric disorders.
- Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations.
- Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system.
- Inability to adhere to study-related procedures.
- Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital General de Granollers
Granollers, Spain, 08402
Hospital de Mataró
Mataró, Spain, 08304
Hospital Universitari de Vic
Vic, Spain, 08500
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrectomy, Prostatectomy
- Being tested
- Radical Nephrectomy (RN), Partial nephrectomy (PN), Radical Prostatectomy (RP)
- Keywords
- Radical nephrectomy, Partial nephrectomy, Radical prostatectomy, Lymphadenectomy, Lysis of adhesions, Robotic surgery, Minimal Invasive surgery, Minimal Invasive robotic surgery, Urology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Nephrectomy (RN)Procedure or surgery
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.
Partial nephrectomy (PN)Procedure or surgery
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.
Radical Prostatectomy (RP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories | Experimental | Not described Receives: Procedure: Radical Nephrectomy (RN); Procedure: Partial nephrectomy (PN); Procedure: Radical Prostatectomy (RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries.
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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Jan 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Surgical Systems S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849271
- Sponsor's protocol ID
- PL-PR01-150
- Acronym
- HYROS-MTC-I
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)
- ClinicalTrials.gov ID
- NCT06849271
- Acronym / sponsor ID
- HYROS-MTC-I / PL-PR01-150
- Conditions
- Nephrectomy, Prostatectomy
- Keywords
- Radical nephrectomy, Partial nephrectomy, Radical prostatectomy, Lymphadenectomy, Lysis of adhesions, Robotic surgery, Minimal Invasive surgery, Minimal Invasive robotic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rob Surgical Systems S.L.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories | Experimental | Procedure: Radical Nephrectomy (RN), Procedure: Partial nephrectomy (PN), Procedure: Radical Prostatectomy (RP) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures.
- Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
- Ability and willingness to comply with all study requirements to be evaluated for each study visit.
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women at the time of the surgery.
- 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.
- Subjects admitted to the hospital due to an emergency situation.
- Subjects with untreated active infection.
- Subject with known allergy to some of the device components (i.e., stainless steel, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories |
| 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 or surgery | Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories |
| 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. | Procedure or surgery | Patients surgically treated with ROB-Bitrack System and ESE/ NESE instruments and accessories |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Nephrectomy (RN), Partial nephrectomy (PN) and Radical Prostatectomy (RP) in people with Nephrectomy and Prostatectomy, run by Rob Surgical Systems S.L. at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (OT) with ROB-Bitrack System and its ESE/NESE Instruments and accessories to perform the surgeries. (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.