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OpenTrials
Completed

NCT Number: NCT03508674

Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System

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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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital La Florida

Santiago, Chile

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levita Magnetic Surgical System

Device

use of surgical tool

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Levita Magnetics

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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