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

Levita Magnetics

Status: Enrolling

Conditions: Hiatal Hernia; Bariatric Surgery Candidate

Treatments: Device: Extended Magnetic Grasper Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06432088

LVT009

CP009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Extended Magnetic Grasper Device

Experimental group

Description:

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.

Treatment:

Device: Extended Magnetic Grasper Device