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

NCT06743256 | Terminated FDA Device

• 1 other identifier: LVT010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Gynecological Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Device and/or Procedure Related Adverse Events

  Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.

  From enrollment to end of follow up at 30 days.

• Average Number of Ports

  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.

  During index procedure.

Study Arms (1)

Magnetic Surgical System in laparoscopic gynecological procedures

EXPERIMENTAL

Device: Surgical System

Interventions

Surgical System DEVICE

Levita Magnetic Surgical System

Magnetic Surgical System in laparoscopic gynecological procedures

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Levita Magnetics: lead

Study Sites (2)

Hospital Clinico San Borja Arriaran

Peñalolén, Santiago Metropolitan, Chile

Location

Hospital Santiago Oriente "Dr. Luis Tisné Brousse"

Peñalolén, Santiago Metropolitan, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 30, 2024
• Primary Completion: April 28, 2025
• Study Completion: June 4, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CL (2)