An interventional study of Use of Levita Magnetics Grasper in Benign Gallbladder Disease, sponsored by Levita Magnetics. Completed at 3 sites in Chile. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Levita Magnetics · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases 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.
Patient is between 18 and 60 years of age
Exclusion Criteria:
Emergency presentation with acute gallbladder disease
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Use of Levita Magnetics Grasper
Safety Assessment of AEs
Absence of any damage or side effect to the patient directly produced by the device during the surgery
Time frame: During surgery
Feasibility of Mobilization
Ability to adequately mobilize the organ during the surgery
Time frame: Intra-operative
| Milestone | Use of Levita Magnetics Grasper |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
Absence of any damage or side effect to the patient directly produced by the device during the surgery
| Participants | Use of Levita Magnetics Grasper |
|---|---|
| No device related adverse events | 50 |
| Device related adverse events | 0 |
Ability to adequately mobilize the organ during the surgery
| Participants | Use of Levita Magnetics Grasper |
|---|---|
| Organ adequately mobilized | 50 |
| Excellent quality of exposure | 45 |
| Sufficient quality of exposure | 5 |
| Insufficient quality of exposure | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Use of Levita Magnetics Grasper | 0/50 (0%) | 2/50 (4%) | 19/50 (38%) |
| Event | Use of Levita Magnetics Grasper |
|---|---|
| hematoma (sub capsular)Skin and subcutaneous tissue disorders | 1/50 |
| subcutaneous emphysemaRespiratory, thoracic and mediastinal disorders | 1/50 |
| extrahepatic bilomaGastrointestinal disorders | 1/50 |
| Event | Use of Levita Magnetics Grasper |
|---|---|
| petechiae, internalSkin and subcutaneous tissue disorders | 19/50 |
| petechiae, externalSkin and subcutaneous tissue disorders | 1/50 |
| Age, Continuous(years) | Use of Levita Magnetics Grasper |
|---|---|
| Mean | 39 ± 12.4 |
| Sex: Female, Male(Participants) | Use of Levita Magnetics Grasper |
|---|---|
| Female | 45 |
| Male | 5 |
| Region of Enrollment(participants) | Use of Levita Magnetics Grasper |
|---|---|
| Chile | 50 |
| BMI(kg/m squared) | Use of Levita Magnetics Grasper |
|---|---|
| Mean | 27.0 ± 3.6 |
| Indication for surgery(participants) | Use of Levita Magnetics Grasper |
|---|---|
| Gallbladder stones | 43 |
| Gallbladder polyps | 7 |
| Ultrasound assessment of gallbladder thickness(mm) | Use of Levita Magnetics Grasper |
|---|---|
| Mean | 1.8 ± 0.5 |
| Ultrasound assessment of abdominal wall thickness(cm) | Use of Levita Magnetics Grasper |
|---|---|
| Mean | 2.6 ± 0.6 |
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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