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

Not Applicable

Completed

• Conditions: Pediatric Lumbar Puncture
• Interventions: Device: Injeq IQ-Needle

• Registration Number: NCT02792660
• Lead Sponsor: Injeq Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Study Start: 2016-07
• Primary Completion: 2018-06
• Status Verified: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injeq IQ-Needle	Injeq IQ-Needle	Lumbar puncture is performed using Injeq IQ-Needle

Primary Outcome Measures

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

Trial Locations

Locations (2)

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland