Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Lap… (NCT06743256) | Clinical Trial Compass
TerminatedNot Applicable
Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
Stopped: The study was terminated early by the sponsor due to slow enrollment.
Chile12 participantsStarted 2024-12-30
Plain-language summary
A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.
Who can participate
Age range18 Years
SexFEMALE
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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.
What they're measuring
1
Number of Participants with Device and/or Procedure Related Adverse Events
Timeframe: From enrollment to end of follow up at 30 days.