Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

L

Levita Magnetics

Status

Completed

Conditions

Bariatric Surgery Candidate

Treatments

Device: Levita Magnetic Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03508674
CP003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

Full description

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Intervention
Experimental group
Description:
Levita Magnetic Surgical System
Treatment:
Device: Levita Magnetic Surgical System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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