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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 colorectal procedures.
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in colorectal procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levita Magnetic Surgical System | Experimental | Levita Magnetic Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levita Magnetic Surgical System | Device | Levita Magnetic Surgical System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues | Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs 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 these tissues during the procedure. Cumulative number of additional tools required across all participants. | During planned colorectal procedure |
| Device Related Adverse Events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post colorectal procedure/study completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I. Emre Gorgun, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Salvador | Santiago | Chile |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levita Magnetic Surgical System | Levita Magnetic Surgical System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levita Magnetic Surgical System | Levita Magnetic Surgical System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 subject did not proceed with procedure. Data was not analyzed. |
| 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 Tools Required to Retract the Colon or Peri-colorectal Tissues | Ability to adequately retract the colon, peri-colorectal tissues or adjacent organs 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 these tissues during the procedure. Cumulative number of additional tools required across all participants. | Posted | Number | Cumulative number of additional tools | During planned colorectal procedure |
|
|
30 days post-procedure
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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 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehiscence Colorectal Anastomosis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Petechias Peritoneal | 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 | May 21, 2019 | Sep 23, 2024 | Prot_SAP_000.pdf |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 1 subject did not proceed with procedure and data was not analyzed. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 1 subject did not proceed with procedure. Data was not analyzed. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
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| Primary | Device Related Adverse Events | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Posted | Number | Number of Device Related Adverse Events | Through 30 days post colorectal procedure/study completion. |
|
|
|
| 30 |
| 4 |
| 30 |
| 6 |
| 30 |
| Pelvic Fluid Collection in Relation to Ileal Pouch | Gastrointestinal disorders | Non-systematic Assessment |
|
| Mechanical Ileus Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Clostridium Infection | Gastrointestinal disorders | Non-systematic Assessment |
|
| Wound Infection | Surgical and medical procedures | Non-systematic Assessment |
|
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