ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
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- STATUS
- Recruiting
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- participants needed
- 400
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- sponsor
- NeuroDx Development
Summary
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Details
| Treatment | ShuntCheck-Micro-Pumper (SCMP), Imaging |
|---|---|
| Clinical Study Identifier | NCT01881711 |
| Sponsor | NeuroDx Development |
| Last Modified on | 7 November 2020 |
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