The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Levita Robotic Platform
Clinica Indisa
Santiago, Santiago Metropolitan, Chile
Hospital FACH
Santiago, Santiago Metropolitan, Chile
Hospital San Borja
Santiago, Santiago Metropolitan, Chile
Hospital Tisne
Santiago, Santiago Metropolitan, Chile
Adverse Events Related to the Device
Total number of adverse events related to the device.
Time frame: 30 days
Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
Number of successfully performed surgeries without the need of additional tools.
Time frame: Interoperatively
Conversion Rate to Open Surgery
Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization.
Time frame: Interoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.