Clinical Evaluation of the Levita Robotic Platform

Last updated: May 10, 2024
Sponsor: Levita Magnetics
Overall Status: Completed

Phase

N/A

Condition

Gall Bladder Disorders

Liver Disorders

Treatment

Levita Robotic Platform

Clinical Study ID

NCT05353777
CP007
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 studyprior to any study required procedures

Exclusion

Exclusion Criteria:

  • • Subjects with pacemakers, defibrillators, or other electromedical implants

  • Subjects with ferromagnetic implants

  • Subjects with significant comorbidities: cardiovascular, neuromuscular, chronicobstructive pulmonary disease, and urological disease (renal failure)

  • Subjects with a clinical history of impaired coagulation confirmed by abnormalblood tests

  • Subject has an anatomical abnormality or disease of intended target tissuenoted after initiation of index procedure that would prevent device use

  • Subject is pregnant or wishes to become pregnant during the length of studyparticipation

  • Subject is not likely to comply with the follow-up evaluation schedule

  • Subject is participating in a clinical trial of another investigational drug ordevice

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: Levita Robotic Platform
Phase:
Study Start date:
May 15, 2021
Estimated Completion Date:
August 29, 2022

Study 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.

Connect with a study center

  • Clinica Indisa

    Santiago, Metropolitana
    Chile

    Site Not Available

  • Hospital FACH

    Santiago, Metropolitana
    Chile

    Site Not Available

  • Hospital San Borja

    Santiago, Metropolitana
    Chile

    Site Not Available

  • Hospital Tisne

    Santiago, Metropolitana
    Chile

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.