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NCT03508674 Clinical Trial

Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Bariatric Surgery Candidate Clinical Trial

Official title:
Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03508674
Other study ID # CP003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2018
Est. completion date September 6, 2018

Study information
Verified date May 2024
Source Levita Magnetics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 6, 2018
Est. primary completion date September 6, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Levita Magnetic Surgical System
use of surgical tool

Locations
Country Name City State
Chile Hospital La Florida Santiago

Sponsors (1)
Lead Sponsor Collaborator
Levita Magnetics

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and types of tools required to mobilize the liver during procedure The ability to mobilize the liver will be evaluated by recording the number and types of tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful. During planned bariatric procedure. (approximately 2 hours on a single day.)
Primary Incidence of device related adverse events (safety) All adverse events will be recorded and allocated as to relatedness to device, procedure or other. Through 30 days post bariatric procedure
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