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 (MARS GI)

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)

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate; Cholelithiases; Other Disease
• Intervention / Treatment: Device: Dual Robotic Arm Accessory (DRAA)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivian Soto; Phone Number: +56958360507; Email: CP008@levita.com

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Clinica Colonial
    • Contact: Pablo Marin, MD
  • Santiago, Chile
    • Not yet recruiting
    • Hospital FACH
    • Contact: Ignacio Robles, MD
  • Metropolitana
    • Santiago, Metropolitana, Chile
      • Recruiting
      • Hospital Tisne
      • Contact: Julio Jimenez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 Prisoner or under incarceration

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Robotic Arm Accessory (DRAA)	Device: Dual Robotic Arm Accessory (DRAA); Dual Robotic Arm Accessory (DRAA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events- Safety	Adverse events related to the device	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Ratio of successful attempts vs unsuccessful attempts	Surgery time
Conversion rate to open surgery	Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization	Surgery time

Collaborators and Investigators

• Sponsor: Levita Magnetics
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Julio Jimenez, MD, Hospital Tisne

Study record dates

Study Major Dates

• Study Start (Anticipated): January 19, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Estimate): January 24, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Disease; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: CP008

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