An interventional study of Extended Magnetic Grasper Device in Bariatric Surgery Candidate and Hiatal Hernia, sponsored by Levita Magnetics. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Levita Magnetics · Not applicable, Interventional, and Other
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.
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.
87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.
Browse Hernia, Hiatal studies →Levita Magnetics is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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.
Time frame: 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.
Time frame: 1 day
| Milestone | Extended Magnetic Grasper Device |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| Device related adverse events | Extended Magnetic Grasper Device |
|---|---|
| Number of Device Related Adverse Events | 0 |
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.
| Procedures w/ additional retractors | Extended Magnetic Grasper Device |
|---|---|
| Mobilization Requiring Additional Retractors | 0 |
Collected over Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Extended Magnetic Grasper Device | 0/30 (0%) | 0/30 (0%) | 14/30 (46.7%) |
| Event | Extended Magnetic Grasper Device |
|---|---|
| PetechiaSkin and subcutaneous tissue disorders | 7/30 |
| Ecchymosis in Surgical IncisionSkin and subcutaneous tissue disorders | 5/30 |
| Liver Capsule Minor AbrasionSurgical and medical procedures | 5/30 |
| Sinus TachycardiaCardiac disorders | 1/30 |
| Transverse Colon InjuryGastrointestinal disorders | 1/30 |
| Atrioventricular BlockCardiac disorders | 1/30 |
| Age, Categorical(Participants) | Extended Magnetic Grasper Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 2 |
| Sex: Female, Male(Participants) | Extended Magnetic Grasper Device |
|---|---|
| Female | 22 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Extended Magnetic Grasper Device |
|---|---|
| Hispanic or Latino | 30 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Extended Magnetic Grasper Device |
|---|---|
| Chile | 30 |
| BMI(kg/m²) | Extended Magnetic Grasper Device |
|---|---|
| Mean | 39.09 ± 5.46 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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