An interventional study of Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). in Nephrectomy and Prostatectomy, sponsored by Rob Surgical Systems S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Rob Surgical Systems S.L. · Not applicable, Interventional, and Treatment
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.
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.
Rob Surgical Systems S.L. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: 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.
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.
Time frame: 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.
Time frame: During the procedure
| Milestone | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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.
| serious adverse events | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention | 0 |
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.
| Score on a scale | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Performance | 4.04 (3.85 to 4.24) |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories | 0/15 (0%) | 0/15 (0%) | 11/15 (73.3%) |
| Event | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Urinary IncontinenceRenal and urinary disorders | 4/15 |
| ConstipationGastrointestinal disorders | 3/15 |
| HaematuriaRenal and urinary disorders | 2/15 |
| HemathomaVascular disorders | 2/15 |
| Urinary Tract InfectionRenal and urinary disorders | 2/15 |
| Hypotensive episodeVascular disorders | 1/15 |
| OedemaGeneral disorders | 1/15 |
| Abdominal discomfortGastrointestinal disorders | 1/15 |
| PneumoperitoneumGastrointestinal disorders | 1/15 |
| Glans InjurySkin and subcutaneous tissue disorders | 1/15 |
Adult subjects between 18 and 90 years old who have provided written informed consent prior to be treated with a robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). During each of these procedures removal of regional lymph nodes (lymphadenectomy) and/or lysis of abdominal lesions could be performed according to patient medical condition and/or surgeon criteria.
| Age, Continuous(years) | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Mean | 64.9 ± 13.0 |
| Sex: Female, Male(Participants) | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Female | 4 |
| Male | 11 |
| Race and Ethnicity Not Collected(Participants) | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|
| BMI(kg/m2) | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Mean | 26.1 ± 3.68 |
| Procedure Type(Participants) | Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories |
|---|---|
| Radical Nephrectomy | 9 |
| Partial Nephrectomy | 1 |
| Radical Prostatectomy | 5 |
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