Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP

N/ACompletedNCT06119568

Rob Surgical Systems S.L.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 PI´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 MIS/MIRS, according to medical criteria. 7. Subjects with life expectancy inferior to 3 months. 8. Subjects with a BMI ≥ 40. 9. Subjects with any contraindication for the use of the 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.

Outcomes

Primary Outcomes

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.