Bariatric Surgery CandidateMARS GINCT05695989
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
A study testing Dual Robotic Arm Accessory (DRAA) in people with Bariatric Surgery Candidate and Cholelithiases, run by Levita Magnetics at 3 sites in Chile.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- What is being tested?
- Dual Robotic Arm Accessory (DRAA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesChile
- Study dates
- 19 Jan 2023to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
3 sites in 1 country.
Chile3 sites
Hospital Tisne
Santiago, Santiago Metropolitan
Clinica Colonial
Santiago
Hospital Fach
Santiago
About this study
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
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)
Read the 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
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Being tested
- Dual Robotic Arm Accessory (DRAA)
- Medical subject headings
- Cholelithiasis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Robotic Arm Accessory (DRAA)Device
Dual Robotic Arm Accessory (DRAA)
| Study group | Role | What they receive |
|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | Experimental | Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. Receives: Device: Dual Robotic Arm Accessory (DRAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events- Safety
Adverse events related to the device
Measured: 30 days
Secondary outcomes (2)
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
Measured: 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
Measured: Surgery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start19 Jan 2023
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levita Magnetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Julio Jimenez, MD, Principal investigator, Hospital Tisne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695989
- Sponsor's protocol ID
- CP008
- Acronym
- MARS GI
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2023
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05695989
- Acronym / sponsor ID
- MARS GI / CP008
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | Experimental | Device: Dual Robotic Arm Accessory (DRAA)Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Subject is at least 18 years of age
Key exclusion criteria (8 listed)
- • Subjects with pacemakers, defibrillators, or other electromedical implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Robotic Arm Accessory (DRAA)Dual Robotic Arm Accessory (DRAA) | Device | DRAA (Dual Robotic Arm Accessory) |
Primary outcome
Adverse Events- Safety
Time frame: 30 days
Adverse events related to the device
2 secondary outcomes
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
Conversion Rate to Open Surgery
Time frame: Surgery time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Jimenez, MD principal investigator
Hospital Tisne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Robotic Arm Accessory (DRAA) in people with Bariatric Surgery Candidate and Cholelithiases, run by Levita Magnetics at 3 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events- Safety (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.