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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 prostatectomy surgery.
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levita Magnetic Surgical System | Experimental | Levita Magnetic Surgical System use of surgical tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levita Magnetic Surgical System | Device | Device for use as a surgical tool. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Tools Required to Retract the Prostate During Procedure | Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure. | During planned prostatectomy procudure |
| Incidence of Device Related Adverse Events (Safety) | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post prostatectomy procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Gettman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Arturo Lopez Perez (FALP) | Santiago | Chile |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levita Magnetic Surgical System | Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levita Magnetic Surgical System | Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Tools Required to Retract the Prostate During Procedure | Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure. | Posted | Number | Additional Tools to Mobilize Liver | During planned prostatectomy procudure |
|
|
Through 30 days post procedure.
All adverse events were recorded and allocated as to relatedness to device, procedure, or other.
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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 | Levita Magnetic Surgical System | Levita Magnetic Surgical System use of surgical tool Levita Magnetic Surgical System: Device for use as a surgical tool. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor bleeding from surgical site on left flank | Surgical and medical procedures | 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 | Oct 12, 2018 | Oct 17, 2024 | Prot_SAP_000.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Incidence of Device Related Adverse Events (Safety) | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Posted | Number | Device Related AEs | Through 30 days post prostatectomy procedure. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 10 |
| 30 |
| Ecchymosis in Assistant Port | Surgical and medical procedures | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment | Investigator further detailed: "lasting for 30 min. (ECG, CK, CKMB and troponin "normal" |
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| Meatal Stenosis | General disorders | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abdominal Wall Hematoma in Assistant Port Placement | Surgical and medical procedures | Non-systematic Assessment |
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| Ecchymosis Around Surgical Sites and Base of Penis Scrotum | Surgical and medical procedures | Non-systematic Assessment |
|
| Infected Pelvic Lymphoceles | General disorders | Non-systematic Assessment |
|
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