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

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

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 Overview

• Status: Recruiting
• Conditions: Plastic Surgery Procedures
• Intervention / Treatment: Device: MACS System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicoletta Campodonico; Phone Number: + 56 9 5696 3953; Email: NCampodonico@Levita.com

Study Locations

• Chile
  • Santiago Metropolitan
    • Las Condes, Santiago Metropolitan, Chile
      • Recruiting
      • Clinica Las Condes
      • Contact: Principal Investigator; Phone Number: +56 2 2610 4000; Email: pacienteinternacional@clinicalascondes.cl
      • Principal Investigator: Susana Benitez Seguel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MACS-Assisted Surgical Procedure; Participants will undergo the planned surgical procedure utilizing the MACS system in accordance with the study protocol and device Instructions for Use (IFU). The MACS will be used as intended to support the surgical procedure. All participants will receive the intervention; no comparator arm is included. Safety and feasibility endpoints will be assessed perioperatively and during the defined follow-up period.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During index procedure.

Collaborators and Investigators

• Sponsor: Levita Magnetics

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LVT012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes