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Completed

NCT Number: NCT04070144

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

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.

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Key information

Conditions

Lumbar Puncture

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, New Children's Hospital, Helsinki, Finland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IQ-Tip(tm) system

Device

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

Primary outcomes

  1. The First Puncture Success Rate

    Time frame: 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

  2. Rate of Serious Adverse Events

    Time frame: 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 outcomes

  1. Percentage of Procedures With Post-dural Puncture Headache (PDPH)

    Time frame: 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.

  2. Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3

    Time frame: 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

  3. Percentage of Procedures With Other Complications or Adverse Events

    Time frame: 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

  4. Aggregate Sensitivity of CSF Detection

    Time frame: 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

  5. Aggregate False Detection Rate of CSF Detection

    Time frame: 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

  6. Number of Required Attempts Per Successful Lumbar Puncture Procedure

    Time frame: 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

  7. Number of Failed Lumbar Puncture Procedures

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Injeq Ltd

Industry

Registry information

Acronym: IQ-LP-03

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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