Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
NCT ID: NCT06743256
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-30
2026-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Magnetic Surgical System in laparoscopic gynecological procedures
Surgical System
Levita Magnetic Surgical System
Interventions
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Surgical System
Levita Magnetic Surgical System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Levita Magnetics
INDUSTRY
Responsible Party
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Locations
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Hospital Clinico San Borja Arriaran
Peñalolén, Santiago Metropolitan, Chile
Hospital Santiago Oriente "Dr. Luis Tisné Brousse"
Peñalolén, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Other Identifiers
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LVT010
Identifier Type: -
Identifier Source: org_study_id