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NCT Number: NCT07470411

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

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.

Recruiting

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Key information

Conditions

Plastic Surgery Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Las Condes

Las Condes, Santiago Metropolitan, Chile

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

+56 2 2610 4000

Susana Benitez Seguel

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MACS System

Device

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.

Primary outcomes

  1. Number of Participants with Device and/or Procedure Related Adverse Events

    Time frame: From enrollment to end of follow up at 30 days.

    Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.

  2. Average Number of Ports

    Time frame: During index procedure.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicoletta Campodonico

CONTACT

[email protected]

+ 56 9 5696 3953

Sponsors and collaborators

Lead sponsor

Levita Magnetics

Industry

Registry information

Official study title

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the MACS in Surgery Procedures

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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