Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical investigation is 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. HYROS-PRnP is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by Bitrack System which operates exclusively under surgeon's orders. The study shall refer to safety and performance of Bitrack System together with its accessories and corresponding ESE/NESE instruments. This study includes the data collected up to 30 days post-surgery and provides 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 will be conducted as a single-center, with a single arm, open-label, and non-randomized design, that will include 15 patients. This clinical investigation aims 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 are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days Follow-up visit, and 30-Days Follow-up visit (remote). 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 total duration of the clinical investigation is expected to be 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients surgically treated with Bitrack System and ESE/ NESE instruments and accessories | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure |
| Performance | Assessment with a "Surgeon performance scale" to confirm that the Bitrack system and ESE/NESE instruments perform as intended during the surgery. | During the procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LluÃs Peri CusÃ, MD | Urology Department, Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2026 | |
| Reset | Jun 25, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2026 | Jun 25, 2026 |
| ID | Term |
|---|---|
| D009392 | Nephrectomy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided