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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 Dual Robotic Arm Accessory (DRAA) 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 Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRAA (Dual Robotic Arm Accessory) | Experimental | Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Robotic Arm Accessory (DRAA) | Device | Dual Robotic Arm Accessory (DRAA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events- Safety | Adverse events related to the device | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | Ratio of successful attempts vs unsuccessful attempts | Surgery time |
| 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 |
|---|---|---|
| Julio Jimenez, MD | Hospital Tisne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Tisne | Santiago | Santiago Metropolitan | Chile | |||
| Clinica Colonial |
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| ID | Title | Description |
|---|---|---|
| FG000 | DRAA (Dual Robotic Arm Accessory) | Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 13, 2022 |
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Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization
| Surgery time |
| Santiago |
| Chile |
| Hospital Fach | Santiago | Chile |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DRAA (Dual Robotic Arm Accessory) | Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. |
| 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 | Participants |
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| 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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| 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- Safety | Adverse events related to the device | Posted | Number | Device related adverse events | 30 days |
|
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| |||||||||||||||||||||||||||
| Secondary | Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon | Ratio of successful attempts vs unsuccessful attempts | Posted | Number | Number Surgeries completed successfully | Surgery time |
|
| ||||||||||||||||||||||||||||
| Secondary | Conversion Rate to Open Surgery | Ratio of conversion from laparoscopic to open surgery due to inability of the robotic system to provide adequate visualization | Posted | Number | Converted procedures | Surgery time |
|
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Adverse events (AE) and serious adverse events (SAEs) were recorded from index procedure through study exit (30 day follow up).
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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 | DRAA (Dual Robotic Arm Accessory) | Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon. | 0 | 20 | 0 | 20 | 12 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Ecchymosis in surgical wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Liver capsule minor abrasion without clinically relevant concern | Surgical and medical procedures | Non-systematic Assessment |
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| Petechia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Soto | Levita Magnetics | +56958360507 | VSoto@Levita.com |
| Dec 30, 2024 |
| Prot_SAP_000.pdf |
| 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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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
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