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

Levita Magnetics

Status

Enrolling

Conditions

Gynecological Laparoscopic Surgery

Treatments

Device: Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06743256

LVT010

Details and patient eligibility

About

A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.