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| Name | Class |
|---|---|
| The Cooper Health System | OTHER |
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The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.
This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Block with CAIG | Experimental | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. |
|
| Peripheral Nerve Block without CAIG | 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 |
|---|---|---|---|---|
| Peripheral Nerve Blocks with CAIG | 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 Identify the Neural Structure(s) and Induce the Peripheral Nerve Block | Immediately after intervention (within 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Rating of the Device | Clinician rates the device on a scale of 1-10. This also includes a questionnaire. | Immediately following intervention (within 2 hours) |
| Number of Attempts | Number of instrument pricks before target is reached |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronak Desai, DO | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cooper Health System | Camden | New Jersey | 08103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peripheral Nerve Block With CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Peripheral Nerve Blocks with CAIG: 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 | Peripheral Nerve Block Without CAIG | 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 | Peripheral Nerve Block With CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Peripheral Nerve Blocks with CAIG: 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, Categorical | Count of Participants |
| 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 Identify the Neural Structure(s) and Induce the Peripheral Nerve Block | Posted | Mean | Standard Deviation | Minutes | Immediately after 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 | Peripheral Nerve Block With CAIG | The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. Peripheral Nerve Blocks with CAIG: 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 | |
|---|---|---|---|---|
| Dr. Ronak Desai | The Cooper Health System | 856-342-2000 | desai-ronak@cooperhealth.edu |
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| Immediately following intervention (within 2 hours) |
| Number of Times Needle Needs Repositioning | Immediately following intervention (within 2 hours) |
| Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire | Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire. | Post-op day 1 |
| Number of Patients That Needed Rescue Opioids | During hospital stay (maximum 3 days) |
| Incidence of Postoperative Nausea and Vomiting | Number of participants that reported postoperative nausea and vomiting | During hospital stay (maximum 3 days) |
| Undesired Muscle Weakness Measured Subjectively | Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer. | During hospital stay (maximum 3 days) |
| BG001 | Peripheral Nerve Block Without CAIG | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
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| Secondary | Clinician Rating of the Device | Clinician rates the device on a scale of 1-10. This also includes a questionnaire. | Data for this outcome measure 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 for 3 (out of 27) participants. | Posted | Mean | Standard Deviation | Attempts | Immediately following intervention (within 2 hours) |
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| Secondary | Number of Times Needle Needs Repositioning | Data for this outcome measure was not collected. | Posted | Immediately following intervention (within 2 hours) |
|
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| Secondary | Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire | Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire. | This data was not collected for 5 (out of 27) participants. | Posted | Mean | Standard Deviation | Units on a Scale | Post-op day 1 |
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| Secondary | Number of Patients That Needed Rescue Opioids | This data was not collected for 4 (out of 27) patients | Posted | Count of Participants | Participants | During hospital stay (maximum 3 days) |
|
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| Secondary | Incidence of Postoperative Nausea and Vomiting | Number of participants that reported postoperative nausea and vomiting | This data was not collected for 4 (out of 27) participants. | Posted | Count of Participants | Participants | During hospital stay (maximum 3 days) |
|
|
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| Secondary | Undesired Muscle Weakness Measured Subjectively | Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer. | This data was not collected for 6 (out of 27) participants. | Posted | Count of Participants | Participants | During hospital stay (maximum 3 days) |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Peripheral Nerve Block Without CAIG | The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | 0 | 14 | 0 | 14 |
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