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: Active, not recruiting

Administrative data

• NCT number: NCT03508674
• Other study ID #: CP003
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: June 2019
• Source: Levita Magnetics
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 30, 2019
• Est. primary completion date: May 30, 2019
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

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