Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

September 20, 2024 updated by: Levita Magnetics
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Hospital La Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Levita Magnetic Surgical System
Device: Levita Magnetic Surgical System
use of surgical tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
Time Frame: During planned bariatric procedure. (approximately 2 hours on a single day.)
The ability to mobilize the liver will be evaluated by recording the number and types of additional 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.)
Number of Participants With Adverse Events and Device Related Adverse Events
Time Frame: Through 30 days post bariatric procedure
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
Through 30 days post bariatric procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Levita Magnetics

Investigators

  • Principal Investigator: Dana Portenier, MD, Duke Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

September 6, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CP003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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