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

Sponsor
Injeq Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02792660
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
28
Actual Duration (Months)
20
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Injeq IQ-Needle
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampere University Hospital Tampere Finland FI-33521
2 Turku University Hospital Turku Finland 20521

Sponsors and Collaborators

  • Injeq Ltd

Investigators

  • Principal Investigator: Vesa Eskola, PhD MD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Injeq Ltd
ClinicalTrials.gov Identifier:
NCT02792660
Other Study ID Numbers:
  • INJ-SPINE-02
First Posted:
Jun 7, 2016
Last Update Posted:
Nov 21, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Nov 21, 2018