NephrectomyNCT06119568
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
A study testing Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). in people with Nephrectomy and Prostatectomy, run by Rob Surgical Systems S.L. at 1 site in Spain.
Trial summary
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of a robot assisted laparoscopic Radical… 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?
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 29 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 PI´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 MIS/MIRS, according to medical criteria.
Show all 14Show fewer
- Subjects with life expectancy inferior to 3 months.
- Subjects with a BMI ≥ 40.
- Subjects with any contraindication for the use of the 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
1 site in 1 country.
About this study
Official title: HYbrid RObotic Surgery in Partial, Radical Nephrectomy and Prostatectomy (HYROS-PRnP)
The purpose of this clinical investigation was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of a robot assisted laparoscopic Radical Nephrectomy (RN), Partial Nephrectomy (PN) or Radical Prostatectomy (RP), as applicable.The HYROS-PRnP study served as a confirmatory investigation, with the primary endpoint hypothesis centered around the effective performance of the Bitrack System and the ESE/NESE instruments and accessories as intended by the surgeon during the intervention.This study included the data collected up to 30 days post-surgery and provided the evidence that the tested medical devices fulfill the GSPR.
Read the detailed description
The Bitrack System is first 4-arms on demand open robotic platform indicated to be used during general abdominal laparoscopic urologic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.
The HYROS-PRnP clinical investigation was planned to be conducted in a single-center, with a single arm, open-label, and non-randomized design to include 15 patients. This clinical investigation aimed to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical nephrectomy, Partial nephrectomy or Radical Prostatectomy surgeries.
The planned visits for this clinical investigation were Baseline (including Screening, Baseline visit, and Informed consent), Procedure, Discharge, 14-Days Follow-up visit (onsite), and 30-Days Follow-up visit (remote). The patient population were adult subjects (between 18 and 90 years old) who had been scheduled for laparoscopic Radical Nephrectomy. Partial Nephrectomy or Radical Prostatectomy. The expected duration of the clinical investigation was 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation would occur when the last visit of the last enrolled subject was completed.
- Conditions
- Nephrectomy, Prostatectomy
- Being tested
- Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).
- Keywords
- Radical nephrectomy, Partial nephrectomy, Radical prostatectomy, Lymphadenectomy, Lysis of adhesions, Robotic surgery, Minimal invasive surgery, Robotic minimal invasive surgery, Urology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).Device
Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
| Study group | Role | What they receive |
|---|---|---|
| Patients surgically treated with Bitrack System and ESE/ NESE instruments and accessories | Experimental | Not described Receives: Device: Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention
Evaluation of Bitrack System to assist in the accurate control of its compatible ESE/NESE instruments, during the intervention without causing any particular SAE related to the use of the medical devices under investigation.
Measured: During the procedure
Performance
Estimation of the global performance score: Assessment with a "Surgeon performance scale", that ranges with the minimum score of 1 (Failure) and the maximun score of 5 (Excellent), to confirm that the Bitrack system and ESE/NESE instruments perform as intended during the surgery. This scale is measured by the surgeon after each surgery.
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 posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Surgical Systems S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lluís Peri Cusí, MD, Principal investigator, Urology Department, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119568
- Sponsor's protocol ID
- PL-PR01-076
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2023
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYbrid RObotic Surgery in Partial, Radical Nephrectomy and Prostatectomy (HYROS-PRnP)
- ClinicalTrials.gov ID
- NCT06119568
- Acronym / sponsor ID
- PL-PR01-076
- Conditions
- Nephrectomy, Prostatectomy
- Keywords
- Radical nephrectomy, Partial nephrectomy, Radical prostatectomy, Lymphadenectomy, Lysis of adhesions, Robotic surgery, Minimal invasive surgery, Robotic minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rob Surgical Systems S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Posted 20 Jul 2026
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 was to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of a robot assisted laparoscopic Radical Nephrectomy (RN), Partial Nephrectomy (PN) or Radical Prostatectomy (RP), as applicable.The HYROS-PRnP study served as a confirmatory investigation, with the primary endpoint hypothesis centered around the effective performance of the Bitrack System and the ESE/NESE instruments and accessories as intended by the surgeon during the intervention.This study included the data collected up to 30 days post-surgery and provided the evidence that the tested medical devices fulfill the GSPR.
Detailed description
The Bitrack System is first 4-arms on demand open robotic platform indicated to be used during general abdominal laparoscopic urologic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.
The HYROS-PRnP clinical investigation was planned to be conducted in a single-center, with a single arm, open-label, and non-randomized design to include 15 patients. This clinical investigation aimed to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical nephrectomy, Partial nephrectomy or Radical Prostatectomy surgeries.
The planned visits for this clinical investigation were Baseline (including Screening, Baseline visit, and Informed consent), Procedure, Discharge, 14-Days Follow-up visit (onsite), and 30-Days Follow-up visit (remote). The patient population were adult subjects (between 18 and 90 years old) who had been scheduled for laparoscopic Radical Nephrectomy. Partial Nephrectomy or Radical Prostatectomy. The expected duration of the clinical investigation was 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation would occur when the last visit of the last enrolled subject was completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients surgically treated with Bitrack System and ESE/ NESE instruments and accessories | Experimental | Device: Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or 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 PI´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 |
|---|---|---|
| Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria. | Device | Patients surgically treated with Bitrack System and ESE/ NESE instruments and accessories |
Primary outcome
Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention
Time frame: During the procedure
Evaluation of Bitrack System to assist in the accurate control of its compatible ESE/NESE instruments, during the intervention without causing any particular SAE related to the use of the medical devices under investigation.
Performance
Time frame: During the procedure
Estimation of the global performance score: Assessment with a "Surgeon performance scale", that ranges with the minimum score of 1 (Failure) and the maximun score of 5 (Excellent), to confirm that the Bitrack system and ESE/NESE instruments perform as intended during the surgery. This scale is measured by the surgeon after each surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lluís Peri Cusí, MD principal investigator
Urology Department, Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). in people with Nephrectomy and Prostatectomy, run by Rob Surgical Systems S.L. at 1 site 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention (time frame: During the procedure). The study lists 2 primary outcomes in all. 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 20 Jul 2026.