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

Levita Magnetics

Status: Not yet enrolling

Conditions: Plastic Surgery Procedures

Treatments: Device: MACS System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07470411

LVT012

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

MACS-Assisted Surgical Procedure

Experimental group

Description:

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.

Treatment:

Device: MACS System