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| Name | Class |
|---|---|
| Rivanna Medical, Inc. | INDUSTRY |
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The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care and neuraxial guidance | Experimental | Spinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACCURO 3S | Device | Provides anatomical guidance during the placement of needles or catheters using real-time visualization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean number of needle attempts | Defined as the number of times the needle is inserted into patients back | At time of procedure, 1 day |
| Mean number of needle redirections | Defined as number of needle movements in a cephalad, caudal or lateral position. | At time of procedure, 1 day |
| Accuracy of device | The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm). | At time of procedure, 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction. | 20 minutes post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Gonzalez-Fiol, MD | Contact | 203-785-2802 | antonio.gonzalez-fiol@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Gonzalez-Fiol, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Anticipated 10 spinal and 40 epidural procedures.
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |