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

NCT06119568 | Completed

• 1 other identifier: PL-PR01-076
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrectomy; Prostatectomy

Keywords

Radical nephrectomy; Partial nephrectomy; Radical prostatectomy; Lymphadenectomy; Lysis of adhesion; Robotic surgery; Minimal invasive surgery; Robotic minimal invasive surgery; Urology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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).

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.

Patients surgically treated with Bitrack System and ESE/ NESE instruments and accessories

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Rob Surgical Systems S.L.: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Nephrectomy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Lluís Peri Cusí, MD

  Urology Department, Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 29, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-01

Locations

ES (1)