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

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

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

Study Overview

• Status: Terminated
• Conditions: Gynecological Laparoscopic Surgery
• Intervention / Treatment: Device: Surgical System

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago Metropolitan
    • Peñalolén, Santiago Metropolitan, Chile
      • Hospital Clinico San Borja Arriaran
    • Peñalolén, Santiago Metropolitan, Chile
      • Hospital Santiago Oriente "Dr. Luis Tisné Brousse"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic Surgical System in laparoscopic gynecological procedures	Device: Surgical System; Levita Magnetic Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Levita Magnetics

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LVT010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes