Assessing the Levita Magnetic Surgical System for gynecological surgeries
Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
NA · Levita Magnetics · NCT06743256
This study is testing a new magnetic surgical system to see if it makes gynecological surgeries safer and helps patients recover faster.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Levita Magnetics (industry) |
| Locations | 2 sites (Peñalolén, Santiago and 1 other locations) |
| Trial ID | NCT06743256 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the Levita Magnetic Surgical System in laparoscopic gynecological procedures across multiple centers. Participants will undergo elective surgeries using this innovative surgical system, which aims to enhance surgical precision and reduce recovery time. The study will involve patients who meet specific eligibility criteria, ensuring a focused assessment of the system's effectiveness and safety in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective gynecological procedures with a BMI of at least 20 kg/m2.
Not a fit: Patients with significant comorbidities, emergency surgical needs, or those with certain medical implants will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to safer and more efficient laparoscopic surgeries for gynecological conditions.
How similar studies have performed: While this approach is innovative, similar studies assessing new surgical technologies have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Peñalolén, Santiago and 1 other locations
- Hospital Clinico San Borja Arriaran — Peñalolén, Santiago, Chile (NOT_YET_RECRUITING)
- Hospital Santiago Oriente "Dr. Luis Tisné Brousse" — Peñalolén, Santiago, Chile (RECRUITING)
Study contacts
- Study coordinator: Vivian Soto
- Email: VSoto@Levita.com
- Phone: +56958360507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gynecological Laparoscopic Surgery