Bariatric Surgery CandidateNCT06432088
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
A study testing Extended Magnetic Grasper Device in people with Bariatric Surgery Candidate and Hiatal Hernia, run by Levita Magnetics at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Hiatal Hernia
- What is being tested?
- Extended Magnetic Grasper Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 13 May 2024to 30 Sep 2024
- 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
- At least 18 years of age.
- Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
- Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.
Who cannot join
- Individuals with pacemakers, defibrillators, or other electromedical implants.
- Individuals with ferromagnetic implants.
- American Society of Anesthesiologists (ASA) score of III or IV.
- Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- Clinical history of impaired coagulation confirmed by abnormal blood tests.
- Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
Show all 11Show fewer
- Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
- Pregnant or wishes to become pregnant during the length of study participation.
- Individual is not likely to comply with the follow-up evaluation schedule.
- Participating in a clinical trial of another investigational drug or device.
- Prisoner or under incarceration.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Santiago Oriente Dr. Luis Tisné Brousse
Santiago, Santiago Metropolitan
About this study
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.
- Conditions
- Bariatric Surgery Candidate, Hiatal Hernia
- Being tested
- Extended Magnetic Grasper Device
- Medical subject headings
- Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Magnetic Grasper DeviceDevice
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
| Study group | Role | What they receive |
|---|---|---|
| Extended Magnetic Grasper Device | Experimental | Evaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. Receives: Device: Extended Magnetic Grasper Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device Related Adverse Events
All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Measured: 30 days
Mobilization Requiring Additional Retractors
Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start13 May 2024
- Primary completion28 Sep 2024
- Study completion30 Sep 2024
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levita Magnetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432088
- Sponsor's protocol ID
- LVT009
- Other IDs
- CP009
- Status last verified
- May 2025
- First submitted
- 16 May 2024
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 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 Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
- ClinicalTrials.gov ID
- NCT06432088
- Acronym / sponsor ID
- LVT009
- Conditions
- Bariatric Surgery Candidate, Hiatal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Levita MagneticsIndustry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Posted 29 May 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 effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended Magnetic Grasper Device | Experimental | Device: Extended Magnetic Grasper DeviceEvaluation of the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age.
- Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
- Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.
Key exclusion criteria (11 listed)
- Individuals with pacemakers, defibrillators, or other electromedical implants.
- Individuals with ferromagnetic implants.
- American Society of Anesthesiologists (ASA) score of III or IV.
- Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- Clinical history of impaired coagulation confirmed by abnormal blood tests.
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 |
|---|---|---|
| Extended Magnetic Grasper DeviceThe purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm. | Device | Extended Magnetic Grasper Device |
Primary outcome
Number of Device Related Adverse Events
Time frame: 30 days
All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Mobilization Requiring Additional Retractors
Time frame: 1 day
Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended Magnetic Grasper Device in people with Bariatric Surgery Candidate and Hiatal Hernia, run by Levita Magnetics at 1 site 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 11 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 29 May 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?
Number of Device Related Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. 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 29 May 2025.