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Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study

RecruitingNAAges 18 Years - anyAllLevita Magnetics
NCT07470411 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * At least 18 years of age * Scheduled to undergo elective surgery procedure within a study cohort * Willing and able to provide written Informed Consent Form (ICF) to participate in the study prior to any study required procedures Exclusion Criteria: * Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure). * Individuals with pacemakers, defibrillators, or other electromedical implants. * Individuals with ferromagnetic implants. * Clinical history of impaired coagulation confirmed by abnormal blood tests. * Pregnant or wishes to become pregnant during the length of study participation. * Individual is not likely to comply with the follow-up evaluation schedule. * Participating in a clinical trial of another investigational drug or device.
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What it tests

  • MACS System
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Where

1 site
Clinica Las Condes
Las Condes, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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