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Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study
Sponsor: Levita Magnetics
Summary
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.
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the MACS in Surgery Procedures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-03-26
Completion Date
2026-12-31
Last Updated
2026-03-13
Healthy Volunteers
Yes
Conditions
Interventions
MACS System
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.
Locations (1)
Clinica Las Condes
Las Condes, Santiago Metropolitan, Chile