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| ID | Type | Description | Link |
|---|---|---|---|
| Grant 13IEAT-20911 | Other Identifier | CORFO |
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The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Levita Magnetics Grasper | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Levita Magnetics Grasper | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment of AEs | Absence of any damage or side effect to the patient directly produced by the device during the surgery | During surgery |
| Feasibility of Mobilization | Ability to adequately mobilize the organ during the surgery | Intra-operative |
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Inclusion Criteria:
Patient is between 18 and 60 years of age
Exclusion Criteria:
Emergency presentation with acute gallbladder disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Luis Tisne | Santiago | Santiago Metropolitan | 7500000 | Chile | ||
| Hospital Padre Hurtado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27759614 | Background | Rivas H, Robles I, Riquelme F, Vivanco M, Jimenez J, Marinkovic B, Uribe M. Magnetic Surgery: Results From First Prospective Clinical Trial in 50 Patients. Ann Surg. 2018 Jan;267(1):88-93. doi: 10.1097/SLA.0000000000002045. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Levita Magnetics Grasper | Use of Levita Magnetics Grasper |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Levita Magnetics Grasper | Use of Levita Magnetics Grasper |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety Assessment of AEs | Absence of any damage or side effect to the patient directly produced by the device during the surgery | Posted | Count of Participants | Participants | During surgery |
|
|
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 | Use of Levita Magnetics Grasper | Use of Levita Magnetics Grasper | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma (sub capsular) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| petechiae, internal | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alberto Rodriguez-Navarro, MD | Levita Magnetics International Corp | 6506557625 | info@levita.com |
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| Santiago |
| Santiago Metropolitan |
| 7500000 |
| Chile |
| Hospital Salvador | Santiago | Santiago Metropolitan | 7500000 | Chile |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m squared |
|
| Indication for surgery | Number | participants |
|
| Ultrasound assessment of gallbladder thickness | Mean | Standard Deviation | mm |
|
| Ultrasound assessment of abdominal wall thickness | Mean | Standard Deviation | cm |
|
|
| Primary | Feasibility of Mobilization | Ability to adequately mobilize the organ during the surgery | Posted | Count of Participants | Participants | Intra-operative |
|
|
|
| 50 |
| 2 |
| 50 |
| 19 |
| 50 |
| subcutaneous emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| extrahepatic biloma | Gastrointestinal disorders | Systematic Assessment |
|
| petechiae, external | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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