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

NCT ID: NCT02792660

Last Updated: 2018-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Lumbar Puncture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Injeq IQ-Needle

Lumbar puncture is performed using Injeq IQ-Needle

Group Type EXPERIMENTAL

Injeq IQ-Needle

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Injeq Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vesa Eskola, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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INJ-SPINE-02

Identifier Type: -

Identifier Source: org_study_id

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