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N/A N=54 Other

Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Bariatric Surgery Candidate

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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