Gynecological Laparoscopic Surgery
Conditions
Brief summary
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Interventions
DEVICESurgical System
Levita Magnetic Surgical System
Sponsors
Levita Magnetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Having a BMI of at least 20 kg/m2 * Scheduled to undergo elective gynecological procedure * Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
Exclusion criteria
* Individuals with BMI higher than 60 kg/m2. * Emergency procedures (e.g., ectopic pregnancy, severe bleeding). * 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. * Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use. * 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 the uterus, adnexal organs, and peri uterine tissue to achieve an effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if an additional port that is typically used for retraction and exposure of target tissues can be eliminated. |
Countries
Chile
Outcome results
None listed