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Completed

NCT Number: NCT05353777

Clinical Evaluation of the Levita Robotic Platform

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)

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Key information

Conditions

Bariatric Surgery Candidate Biliary Tract Diseases Cholelithiases Cholelithiasis Digestive System Diseases Disease Other Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Indisa, Santiago, Santiago Metropolitan, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Levita Robotic Platform

Device

Levita Robotic Platform

Primary outcomes

  1. Adverse Events Related to the Device

    Time frame: 30 days

    Total number of adverse events related to the device.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Levita Magnetics

Industry

Collaborators

  • The Cleveland Clinic

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
May 28, 2025

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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