Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures

Not Applicable

Recruiting

• Conditions: Gynecological Laparoscopic Surgery

• Registration Number: NCT06743256
• Lead Sponsor: Levita Magnetics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Study Start: 2024-12-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-09-07
• Study Completion: 2025-10-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hospital Clinico San Borja Arriaran; 🇨🇱 Peñalolén, Santiago, Chile

Hospital Santiago Oriente "Dr. Luis Tisné Brousse"; 🇨🇱 Peñalolén, Santiago, Chile