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OpenTrials
Completed

NCT Number: NCT02792660

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.

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Key information

Conditions

Pediatric Lumbar Puncture

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital, Tampere, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: During lumbar puncture

    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.

Sponsors and collaborators

Lead sponsor

Injeq Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2016
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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