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Completed

NCT Number: NCT05695989

Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) 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

Hospital Tisne, 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 Dual Robotic Arm Accessory 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 Prisoner or under incarceration

Treatment and study plan

Dual Robotic Arm Accessory (DRAA)

Device

Dual Robotic Arm Accessory (DRAA)

Primary outcomes

  1. Adverse Events- Safety

    Time frame: 30 days

    Adverse events related to the device

Secondary outcomes

  1. Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon

    Time frame: Surgery time

    Ratio of successful attempts vs unsuccessful attempts

  2. Conversion Rate to Open Surgery

    Time frame: Surgery time

    Ratio of 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

Official study title

Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

Acronym: MARS GI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Feb 21, 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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