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| Name | Class |
|---|---|
| The Cooper Health System | OTHER |
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The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.
The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAIG | Experimental | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. |
|
| Control | No Intervention | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. | Device | The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Needed to Correctly Insert the Arterial or Midline Catheter. | Immediately following intervention (within 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Rating of the Device | Immediately following intervention (within 2 hours) | |
| Number of Attempts | Number of instrument pricks before target is reached | Immediately following intervention (within 2 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irwin Gratz, DO | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cooper Health System | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34637140 | Derived | Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. |
| FG001 | Control | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | At least 18 years of age | This data was not collected |
| 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 | Time Needed to Correctly Insert the Arterial or Midline Catheter. | Posted | Mean | Standard Deviation | Seconds | Immediately following intervention (within 2 hours) |
|
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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 | CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irwin Gratz | The Cooper Health System | 856-968-8527 | gratz-irwin@cooperhealth.edu |
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|
|
| Number of Times Needle Needs Repositioning | Immediately following intervention (within 2 hours) |
| BG001 | Control | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
|
|
| Secondary | Clinician Rating of the Device | This data was not collected | Posted | Immediately following intervention (within 2 hours) |
|
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| Secondary | Number of Attempts | Number of instrument pricks before target is reached | This data was not collected | Posted | Immediately following intervention (within 2 hours) |
|
|
| Secondary | Number of Times Needle Needs Repositioning | This data was not collected | Posted | Immediately following intervention (within 2 hours) |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | 0 | 15 | 0 | 15 |
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