Status:
COMPLETED
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
Lead Sponsor:
Rob Surgical Systems S.L.
Conditions:
Nephrectomy
Prostatectomy
Eligibility:
All Genders
18-90 years
Phase:
NA
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 En...
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 accu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06119568
Start Date
November 1 2023
End Date
April 29 2024
Last Update
May 29 2024
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036