Back to resultsIdentification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Primary Purpose
Pediatric Lumbar Puncture
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Injeq IQ-Needle
Sponsored by
About this trial
This is an interventional other trial for Pediatric Lumbar Puncture
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injeq IQ-Needle
Arm Description
Lumbar puncture is performed using Injeq IQ-Needle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02792660
Brief Title
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Official Title
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Injeq Ltd
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Lumbar Puncture
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injeq IQ-Needle
Arm Type
Experimental
Arm Description
Lumbar puncture is performed using Injeq IQ-Needle
Intervention Type
Device
Intervention Name(s)
Injeq IQ-Needle
Intervention Description
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 Outcome Measure Information:
Title
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
Description
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.
Time Frame
During lumbar puncture
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vesa Eskola, PhD MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
FI-33521
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
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