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

Injeq Ltd40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pediatric Lumbar Puncture

Interventions

Injeq IQ-NeedleDEVICE

Injeq IQ-Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.

Eligibility

Sex: ALLMax age: 18 Months

Medical Language ↔ Plain English

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

Locations (2)

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

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

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.

Time frame: During lumbar puncture

Data from ClinicalTrials.gov

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