Plastic Surgery ProceduresNCT07470411
Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study
A study testing MACS System in people with Plastic Surgery Procedures, run by Levita Magnetics at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plastic Surgery Procedures
- What is being tested?
- MACS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 20 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clinica Las Condes
Las Condes, Santiago Metropolitan
Principal Investigator, +56 2 2610 4000, pacienteinternacional@clinicalascondes.cl
Susana Benitez Seguel
About this study
Official title: 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.
- Conditions
- Plastic Surgery Procedures
- Being tested
- MACS System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACS SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MACS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start20 Apr 2026
- Primary completion28 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plastic Surgery ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Levita Magnetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470411
- Sponsor's protocol ID
- LVT012
- Status last verified
- May 2026
- First submitted
- 4 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the MACS in Surgery Procedures
- ClinicalTrials.gov ID
- NCT07470411
- Acronym / sponsor ID
- LVT012
- Conditions
- Plastic Surgery Procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MACS-Assisted Surgical Procedure | Experimental | Device: MACS SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACS SystemThe 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. | Device | MACS-Assisted Surgical Procedure |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Plastic Surgery Procedures
RecruitingObservational study
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
Reconstructive Surgical Procedures, Plastic Surgery
RecruitingObservational study
Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
Physiologic Venous Dilation, Air Travel
Recruiting
Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums
Recession, Gingival
Active, not recruiting
Quality of Life, Aesthetic Result and Health Economy in Breast Reconstruction
Breast Cancer Female, Surgery--Complications
Recruiting
Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Refractory Granulomatous Lobular Mastitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACS System in people with Plastic Surgery Procedures, run by Levita Magnetics at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicoletta Campodonico (+ 56 9 5696 3953, NCampodonico@Levita.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Device and/or Procedure Related Adverse Events (time frame: From enrollment to end of follow up at 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.