---
title: "Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study"
nct_id: NCT07470411
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Levita Magnetics
study_type: INTERVENTIONAL
primary_condition: Plastic Surgery Procedures
countries: Chile
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07470411.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07470411"
ct_last_update_post_date: 2026-03-13
last_seen_at: "2026-05-12T06:34:02.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study

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

**NCT ID:** [NCT07470411](https://clinicaltrials.gov/study/NCT07470411)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Levita Magnetics
- **Conditions:** Plastic Surgery Procedures
- **Start Date:** 2026-03-26
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-03-13

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **MACS-Assisted Surgical Procedure** (EXPERIMENTAL) — 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.

## Interventions

- **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

- **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.
- **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.

## Locations (1)

- Clinica Las Condes, Las Condes, Santiago Metropolitan, Chile

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinica las condes|las condes|santiago metropolitan|chile` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07470411.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07470411*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*