Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2018-09-06

Brief Summary

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

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Detailed Description

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

Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Levita Magnetic Surgical System

Group Type EXPERIMENTAL

Levita Magnetic Surgical System

Intervention Type DEVICE

use of surgical tool

Interventions

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Levita Magnetic Surgical System

use of surgical tool

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No