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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levita Robotic Platform | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levita Robotic Platform | Device | Levita Robotic Platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Related to the Device | Total number of adverse events related to the device. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | Number of successfully performed surgeries without the need of additional tools. | Interoperatively |
| Conversion Rate to Open Surgery |
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Inclusion Criteria:
• Subject is at least 18 years of age
Exclusion Criteria:
• Subjects with pacemakers, defibrillators, or other electromedical implants
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Robles, MD | Hospital FACH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Indisa | Santiago | Santiago Metropolitan | Chile | |||
| Hospital FACH |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levita Robotic Platform | Levita Robotic Platform: Levita Robotic Platform |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levita Robotic Platform | Levita Robotic Platform: Levita Robotic Platform |
| 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 | Adverse Events Related to the Device | Total number of adverse events related to the device. | Posted | Number | Adverse events related to device | 30 days |
|
|
Adverse events were documented throughout the course of the study up to thirty (30) days post op.
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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 Robotic Platform | Levita Robotic Platform: Levita Robotic Platform | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal 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 | Jan 12, 2021 | Jan 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization. |
| Interoperatively |
| Santiago |
| Santiago Metropolitan |
| Chile |
| Hospital San Borja | Santiago | Santiago Metropolitan | Chile |
| Hospital Tisne | Santiago | Santiago Metropolitan | Chile |
| 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 |
|
|
| Secondary | Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | Number of successfully performed surgeries without the need of additional tools. | Posted | Number | Successfully performed surgeries | Interoperatively |
|
|
|
| Secondary | Conversion Rate to Open Surgery | Conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization. | Posted | Number | Converted procedures | Interoperatively |
|
|
|
| 46 |
| 1 |
| 46 |
| 15 |
| 46 |
| Anal Fissure | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Short vessel bleeding | Surgical and medical procedures | Non-systematic Assessment |
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| Nausea and Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Liver Capsule Minor Abrasion | Surgical and medical procedures | Non-systematic Assessment |
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| Allergy Rush | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petechia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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