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

Not Applicable

Completed

Conditions: Lumbar Puncture

Interventions: Device: IQ-Tip(tm) system

Registration Number: NCT04070144

Lead Sponsor: Injeq Ltd

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IQ-Tip	IQ-Tip(tm) system	At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant

Primary Outcome Measures

Name	Time	Method
The First Puncture Success Rate	The assessment immediately following each lumbar puncture procedure	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
Rate of Serious Adverse Events	The assessment during four-week follow-up after each lumbar puncture procedure	Total number of serious adverse events caused by the device. Serious adverse event in probable or causal relationship to the investigational device exposure

Secondary Outcome Measures

Name	Time	Method
Percentage of Procedures With Post-dural Puncture Headache (PDPH)	The assessment during 7-day follow-up after each lumbar puncture procedure	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.
Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3	The laboratory analysis within 3 hours of the lumbar puncture	Erythrocyte (red blood cell) count according to laboratory analysis in units of 10\^6/liter or 1/mm3
Percentage of Procedures With Other Complications or Adverse Events	The assessment during 7-day and four-week follow ups	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
Aggregate Sensitivity of CSF Detection	The assessment immediately following each lumbar puncture procedure	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
Aggregate False Detection Rate of CSF Detection	The assessment immediately following each lumbar puncture procedure	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
Number of Required Attempts Per Successful Lumbar Puncture Procedure	The assessment immediately following each 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
Number of Failed Lumbar Puncture Procedures	The assessment immediately following each lumbar puncture procedure	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

Trial Locations

Locations (3): Turku University Hospital
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Turku, Finland
Helsinki University Hospital, New Children's Hospital
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Helsinki, Finland
Tampere University Hospital
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Tampere, Finland