The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) 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 Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Dual Robotic Arm Accessory (DRAA)
Hospital Tisne
Santiago, Santiago Metropolitan, Chile
Clinica Colonial
Santiago, Chile
Hospital Fach
Santiago, Chile
Adverse Events- Safety
Adverse events related to the device
Time frame: 30 days
Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
Ratio of successful attempts vs unsuccessful attempts
Time frame: Surgery time
Conversion Rate to Open Surgery
Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization
Time frame: Surgery time
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