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

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 Overview

• Status: Completed
• Conditions: Pediatric Lumbar Puncture
• Intervention / Treatment: Device: Injeq IQ-Needle

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, FI-33521
    • Tampere University Hospital
  • Turku, Finland, 20521
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Injeq IQ-Needle; Lumbar puncture is performed using Injeq IQ-Needle

Device: Injeq IQ-Needle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Injeq Ltd
• Investigators: Principal Investigator: Vesa Eskola, PhD MD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: INJ-SPINE-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No