N/A
Completed N=30
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
Bariatric Surgery Candidate · Hiatal Hernia
Source: ClinicalTrials.gov NCT06432088 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Number of Device Related Adverse Events — 0 Device related adverse events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Device Related Adverse Events |
— | — |
| PRIMARY Mobilization Requiring Additional Retractors |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06432088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.