Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.

Study Overview

• Status: Completed
• Conditions: Hiatal Hernia; Bariatric Surgery Candidate
• Intervention / Treatment: Device: Extended Magnetic Grasper Device

Detailed Description

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, 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.
• Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
• 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 pacemakers, defibrillators, or other electromedical implants.
• Individuals with ferromagnetic implants.
• American Society of Anesthesiologists (ASA) score of III or IV.
• Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
• Clinical history of impaired coagulation confirmed by abnormal blood tests.
• Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
• 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.
• Prisoner or under incarceration.

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: Extended Magnetic Grasper Device; Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.	Device: Extended Magnetic Grasper Device; The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Device Related Adverse Events	All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.	30 days
Mobilization Requiring Additional Retractors	Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.	1 day

Collaborators and Investigators

• Sponsor: Levita Magnetics

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): September 28, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Hernia; Hernia, Diaphragmatic; Hernia, Hiatal
• Other Study ID Numbers: LVT009; CP009 (Other Identifier: Levita Magnetics)

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: No
• product manufactured in and exported from the U.S.: No