NCT07470411

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Levita Magnetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plastic Surgery Procedures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-26
• Primary completion: 2026-11-28
• Completion: 2026-12-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Chile

Regulatory

• FDA-regulated device study