Clinical Evaluation of the Levita Robotic Platform

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    100
  • sponsor
    Levita Magnetics
Updated on 16 May 2022

Summary

The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

Description

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.

Details
Condition Bariatric Surgery Candidate, Cholelithiases, Other Disease
Treatment Levita Robotic Platform
Clinical Study IdentifierNCT05353777
SponsorLevita Magnetics
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Subject is at least 18 years of age
Subject is scheduled to undergo elective laparoscopic procedure
Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria

• Subjects with pacemakers, defibrillators, or other electromedical implants
Subjects with ferromagnetic implants
Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
Subject is pregnant or wishes to become pregnant during the length of study participation
Subject is not likely to comply with the follow-up evaluation schedule
Subject is participating in a clinical trial of another investigational drug or device
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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