The goal of this clinical trial is to evaluate the safety and performance of the MACS device in adults undergoing elective plastic surgery procedures. Participants will undergo their planned surgical procedure in which the MACS device will be used as part of the procedure. Participants will be monitored during and after surgery to assess device performance and to identify any medical problems (adverse events) that may occur following use of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The MACS System is an investigational surgical device intended for use during surgical procedures as specified in the study protocol. The device will be utilized by qualified surgeons in accordance with the Instructions for Use (IFU) to support the intended surgical function. The study will evaluate the safety and feasibility of the MACS System when used during the planned procedure.
Clinica Las Condes
Las Condes, Santiago Metropolitan, Chile
Number of Participants with Device and/or Procedure Related Adverse Events
Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Time frame: From enrollment to end of follow up at 30 days.
Average Number of Ports
Ability to adequately retract tissue to achieve an effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if there is a reduction of the incision size or at least one conventional retractor is avoided compared to the investigator's standard practice.
Time frame: During index procedure.
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