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

Pediatric Lumbar Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792660
• Other study ID #: INJ-SPINE-02
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Injeq Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Lumbar Puncture

Intervention

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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Injeq Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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