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

NCT02792660 | Completed

• 1 other identifier: INJ-SPINE-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• 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.

  During lumbar puncture

Study Arms (1)

Injeq IQ-Needle

EXPERIMENTAL

Lumbar puncture is performed using Injeq IQ-Needle

Device: Injeq IQ-Needle

Interventions

Injeq IQ-Needle DEVICE

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.

Injeq IQ-Needle

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
• Consent from the parents

You may not qualify if:

• Being a high risk patient (as determined by the investigator)
• Any contraindication to a common lumbar puncture apply also in the investigation

Sponsors & Collaborators

• Injeq Ltd: lead

Study Sites (2)

Tampere University Hospital

Tampere, FI-33521, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Study Officials

• Vesa Eskola, PhD MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)