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 Overview
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Brief Summary
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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)

Detailed Description
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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

Official Title
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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

Conditions
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Bariatric Surgery Candidate, Cholelithiases, Other Disease

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Robotic Arm Accessory (DRAA)<br> | Device: Dual Robotic Arm Accessory (DRAA)<br>* Dual Robotic Arm Accessory (DRAA)<br>|

What is the study measuring?
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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 |