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

NCT06432088 | Completed Results

• 2 other identifiers: LVT009CP009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate; Hiatal Hernia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Extended Magnetic Grasper Device

EXPERIMENTAL

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

Interventions

Extended Magnetic Grasper Device 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.

Extended Magnetic Grasper Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Levita Magnetics: lead

Study Sites (1)

Hospital Santiago Oriente Dr. Luis Tisné Brousse

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vivian Soto
• Organization: Levita Magnetics

VSoto@Levita.com

+56958360507

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: May 16, 2024
• First Posted: May 29, 2024
• Study Start: May 13, 2024
• Primary Completion: September 28, 2024
• Study Completion: September 30, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Locations

CL (1)