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 Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.

• 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.

Primary outcomes

• Number of Device Related Adverse Events [30 days]: 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.
• Mobilization Requiring Additional Retractors [1 day]: 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.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Number of Device Related Adverse Events (Primary), Number, Device related adverse events: Extended Magnetic Grasper Device 0
• Mobilization Requiring Additional Retractors (Primary), Number, Procedures w/ additional retractors: Extended Magnetic Grasper Device 0

Adverse events

Time frame: Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2024-06-19)