N/A
N=54
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
Bariatric Surgery Candidate
Bottom Line
View on ClinicalTrials.gov: NCT03508674 ↗Enrolled (actual)
54
Serious AEs
3.7%
Results posted
Oct 2024
Primary outcome: Primary: Number and Types of Additional Tools Required to Mobilize the Liver During Procedure — 0 Additional Tools to Mobilize Liver
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levita Magnetic Surgical System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Levita Magnetics
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Types of Additional Tools Required to Mobilize the Liver During Procedure |
— | — |
| PRIMARY Number of Participants With Adverse Events and Device Related Adverse Events |
17; 14 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
Eligibility Criteria
Inclusion Criteria
- at least 18 years of age
- scheduled to undergo bariatric procedure
Exclusion Criteria
- Am Soc Anesthesiology score of III or IV
- significant comorbidities
- subjects contraindicated for use of magnetic system
- clinical history of impaired coagulation
- hepatic abnormality or anatomical abnormality
Data sourced from ClinicalTrials.gov (NCT03508674). 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.