Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study (NCT07470411) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study
Chile50 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Device and/or Procedure Related Adverse Events
Timeframe: From enrollment to end of follow up at 30 days.