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To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter placement with Solopass system | Experimental | The Solopass US system will be used during catheter placement procedure to guide the placement of the catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Placement with Solopass System | Device | This device is used as a guidance for placing a brain catheter to target the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain. |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of passes needed to place the catheter in each subject. | Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted. | 0 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system | Grade 1 means optimal placement in the ipsilateral frontal horn or third ventricle; Grade 2 means a functional placement in the contralateral lateral ventricle or no eloquent cortex; and Grade 3 means suboptimal placement in the eloquent cortex or nontarget cerebrospinal fluid space, with or without functional drainage |
| Measure | Description | Time Frame |
|---|---|---|
| Length of time of the procedure | Number of minutes necessary to complete the procedure placement of the catheter | Up to three hours |
| Number of revision | Quantity of revisions due to the catheter malfunction |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Craig, MNR, BS | Contact | 717-531-0003 | 285799 | scraig2@pennstatehealth.psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| J C Zacko, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| up to 7 days |
| up to 7 days |
| Number of subjects with Cerebrospinal fluid (CSF) infection | CSF will be collected as part of standard of care after the procedure and tested for infection. | up to 7 days |
| Number of subjects with Superficial surgical site infection (SSI) | (The CDC defines SSI as deep and superficial. A superficial incisional SSI is an infection in the area of the skin where the incision was made. A deep incisional SSI occurs beneath the incision area in the muscle and the tissues surrounding the muscles. Signs to be monitored daily and put in a checklist will include redness, pain, unexplained fever source, pain, warmth, pus or swelling.) | up to 7 days |
| Longevity of the device function | Number of days until a subsequent catheter is placed | up to 7 days |