The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures

Study Overview
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Brief Summary
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The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures.

Detailed Description
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The primary purpose of the investigation is to demonstrate the claimed clinical benefit and safety of Injeq IQ-Tip™ system. IQ-Tip™ is similar to common spinal needles with a custom-made stylet that enables the real-time bioimpedance measurement at the tip of the needle. The needle is connected to the analyzer device, which provides real-time CSF detection during lumbar puncture from the very tip of the needle and by these means assists conducting the medical procedure. The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures. The investigation is conducted in the pediatric hematology and oncology units of three Finnish university hospitals

Official Title
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The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures

Conditions
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Lumbar Puncture

Intervention / Treatment
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* Device: IQ-Tip(tm) system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric hemato-oncology patients whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample or to inject drug or other substance Written and signed informed consent before the procedure from the parent and/or patient depending on the age of the patient Exclusion Criteria: Parents and/or patient refusal to participate or parents and/or patient unable to give informed consent Any contraindications to a lumbar puncture. Contraindications include skin infection around the puncture area, unstable hemodynamics, bleeding tendency and increased intracranial pressure

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IQ-Tip<br>At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant | Device: IQ-Tip(tm) system<br>* Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The First Puncture Success Rate | Each individual lumbar puncture procedure is assessed as either 'first puncture success' or '-failure'. Success rate = Successes / All procedures Definition of the first puncture success: Only one skin puncture with the needle is allowed; Multiple stylet removals and reinsertions are allowed; Multiple needle reorientations are allowed as long as needle tip remains inside the skin; Physician must be able obtain a cerebrospinal fluid (CSF) sample that is sent to a laboratory analysis or to inject the intended medication to the patient's subarachnoid space; and Physician conducting the puncture remains the same during the procedure | The assessment immediately following each lumbar puncture procedure | 
| Rate of Serious Adverse Events | Total number of serious adverse events caused by the device. Serious adverse event in probable or causal relationship to the investigational device exposure | The assessment during four-week follow-up after each lumbar puncture procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Procedures With Post-dural Puncture Headache (PDPH) | PDPH defined as headache that: worsens in sitting or standing position eases when lying down occurs within 7 days after the lumbar puncture procedure Possible symptoms are recording using a diary filled by the patient or parents and verified by the study nurse. | The assessment during 7-day follow-up after each lumbar puncture procedure | 
| Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3 | Erythrocyte (red blood cell) count according to laboratory analysis in units of 10^6/liter or 1/mm3 | The laboratory analysis within 3 hours of the lumbar puncture | 
| Percentage of Procedures With Other Complications or Adverse Events | E.g. PDPH or backache Possible symptoms are recorded using a diary filled by the patient or parents and verified by the study nurse. Diary is an open questionaire that is intended for recording any possible complication. Possible complications are not considered as pre-determined outcome measures, with the exception of Outcome #3 (rate of PDPH) Four-week follow up conducted by the study nurse from the hospital registers | The assessment during 7-day and four-week follow ups | 
| Aggregate Sensitivity of CSF Detection | The CSF detection performance of the investigational device is assessed by the physician. Each individual lumbar puncture procedure is classified as either 'True Positive CSF detection (TP)', 'False Negative CSF detection (FN)' or 'Procedure failed (Fail)' by the investigator. The aggregate sensitivity = Number of TPs / Total number of procedures | The assessment immediately following each lumbar puncture procedure | 
| Aggregate False Detection Rate of CSF Detection | Each individual lumbar puncture procedure is classified as either 'One or more False Positive CSF detections (FP)' or 'No False Positive CSF detections (TN)'. The aggregate false detection rate = Number of FPs / Total number of procedures | The assessment immediately following each lumbar puncture procedure | 
| Number of Required Attempts Per Successful Lumbar Puncture Procedure | In line with definition of 'the first puncture success rate', attempt is defined as: any new penetration of skin is considered a new attempt. Lumbar puncture is considered successful irrespective of the number of punctures if the CSF sample was eventually obtained and/or the injection of medicine could be performed | The assessment immediately following each lumbar puncture procedure | 
| Number of Failed Lumbar Puncture Procedures | Procedure is considered failed if physicians, even after multiple attempts, conclude that the lumbar puncture cannot be completed with available personnel or equipment due to any reason | The assessment immediately following each lumbar puncture procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal puncture, Lumbar puncture