MARS GI: 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

• Sponsor: Levita Magnetics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05695989
• Collaborator: The Cleveland Clinic (Other)
• Enrollment: 50
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 11.4
• Patients Per Site: 16.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate; Cholelithiases; Other Disease	Device: Dual Robotic Arm Accessory (DRAA)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Anticipated Study Start Date: Jan 19, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse events- Safety [30 days]

   Adverse events related to the device

Secondary Outcome Measures

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 [Surgery time]

   Ratio of successful attempts vs unsuccessful attempts

2. Conversion rate to open surgery [Surgery time]

   Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Tisne	Santiago	Metropolitana	Chile
2	Clinica Colonial	Santiago		Chile
3	Hospital Fach	Santiago		Chile

Sponsors and Collaborators

• Levita Magnetics
• The Cleveland Clinic

Investigators

• Principal Investigator: Julio Jimenez, MD, Hospital Tisne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Levita Magnetics
• ClinicalTrials.gov Identifier: NCT05695989
• Other Study ID Numbers: CP008
• First Posted: Jan 25, 2023
• Last Update Posted: Jan 25, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Disease

Study Results

No Results Posted as of Jan 25, 2023