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

Injeq

Status: Completed

Conditions: Pediatric Lumbar Puncture

Treatments: Device: Injeq IQ-Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792660

INJ-SPINE-02

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: Under 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Injeq IQ-Needle

Experimental group

Description:

Lumbar puncture is performed using Injeq IQ-Needle

Treatment:

Device: Injeq IQ-Needle