- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695989
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)
January 13, 2023 updated by: Levita Magnetics
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vivian Soto
- Phone Number: +56958360507
- Email: CP008@levita.com
Study Locations
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
Time Frame: 30 days
|
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
Time Frame: Surgery time
|
Ratio of successful attempts vs unsuccessful attempts
|
Surgery time
|
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
|
Surgery time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julio Jimenez, MD, Hospital Tisne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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