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

Injeq Ltd50 enrolled

Overview

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 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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lumbar Puncture

Interventions

IQ-Tip(tm) systemDEVICE

Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Helsinki University Hospital, New Children's Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: The assessment during four-week follow-up after each lumbar puncture procedure

Secondary Outcomes

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.

Time frame: 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

Time frame: The laboratory analysis within 3 hours of the lumbar puncture

Percentage of Procedures With Other Complications or Adverse Events

Data from ClinicalTrials.gov

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