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The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Levita Magnetic Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levita Magnetic Surgical System | Device | use of surgical tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Types of Additional Tools Required to Mobilize the Liver During Procedure | The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful. | During planned bariatric procedure. (approximately 2 hours on a single day.) |
| Number of Participants With Adverse Events and Device Related Adverse Events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post bariatric procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Portenier, MD | Duke Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Florida | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33011073 | Derived | Luengas R, Galindo J, Castro M, Marambio A, Watkins G, Rodriguez Del Rey M, Davanzo C, Portenier D, Guerron AD. First prospective clinical trial of reduced incision bariatric procedures using magnetic liver retraction. Surg Obes Relat Dis. 2021 Jan;17(1):147-152. doi: 10.1016/j.soard.2020.08.017. Epub 2020 Aug 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Levita Magnetic Surgical System Levita Magnetic Surgical System: use of surgical tool |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Levita Magnetic Surgical System Levita Magnetic Surgical System: use of surgical tool |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Types of Additional Tools Required to Mobilize the Liver During Procedure | The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful. | Posted | Number | Additional Tools to Mobilize Liver | During planned bariatric procedure. (approximately 2 hours on a single day.) |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Levita Magnetic Surgical System Levita Magnetic Surgical System: use of surgical tool |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Soto | Levita Magnetics | +56958360507 | VSoto@Levita.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2018 | Aug 26, 2024 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Number of Participants With Adverse Events and Device Related Adverse Events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Posted | Number | participants | Through 30 days post bariatric procedure |
|
|
|
| 0 |
| 54 |
| 2 |
| 54 |
| 15 |
| 54 |
| Abdominal Pain and Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Liver Capsule Superficial Erosion Without Bleeding | Hepatobiliary disorders | Non-systematic Assessment |
|
| Liver Capsule Superficial Abrasion Without Bleeding | Hepatobiliary disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hepatic Hematoma | Hepatobiliary disorders | Non-systematic Assessment |
|
| Acute Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
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