Plastic Surgery Procedures
Conditions
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.
Interventions
DEVICEMACS 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.
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Device and/or Procedure Related Adverse Events | 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 | 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. |
Countries
Chile
Contacts
CONTACTNicoletta Campodonico
Outcome results
None listed