Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pediatric Lumbar Puncture
- Sponsor
- Injeq Ltd
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
- •Consent from the parents
Exclusion Criteria
- •Being a high risk patient (as determined by the investigator)
- •Any contraindication to a common lumbar puncture apply also in the investigation
Outcomes
Primary Outcomes
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
Time Frame: During lumbar puncture
Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect CSF, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the lumbar puncture and were the detections true or false detections.