CompletedNot Applicable

Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture

Finland40 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range18 Months

SexALL

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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

What they're measuring

Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form

Timeframe: During lumbar puncture

Trial details

NCT IDNCT02792660

SponsorInjeq Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Pediatric Lumbar Puncture trials