Clinical Evaluation of the Levita Robotic Platform

May 9, 2025 updated by: Levita Magnetics
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

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
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Clinica Indisa
      • Santiago, Metropolitana, Chile
        • Hospital FACH
      • Santiago, Metropolitana, Chile
        • Hospital San Borja
      • Santiago, Metropolitana, Chile
        • Hospital Tisne

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:

  • • 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levita Robotic Platform
Device: Levita Robotic Platform
Levita Robotic Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Related to the Device
Time Frame: 30 days
Total number of adverse events related to the device.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
Time Frame: Interoperatively
Number of successfully performed surgeries without the need of additional tools.
Interoperatively
Conversion Rate to Open Surgery
Time Frame: Interoperatively
Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization.
Interoperatively

Collaborators and Investigators

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

Sponsor

Levita Magnetics

Collaborators

The Cleveland Clinic

Investigators

  • Principal Investigator: Ignacio Robles, MD, Hospital FACH

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)

May 15, 2021

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

August 29, 2022

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP007

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

No

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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