Clinical trial NCT04070144: The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Official title: The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Puncture
Keywords: Spinal puncture
Lumbar puncture
Lead sponsor: Injeq Ltd
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: The First Puncture Success Rate
timeFrame: The assessment immediately following each lumbar puncture procedure
measure: Rate of Serious Adverse Events
timeFrame: The assessment during four-week follow-up after each lumbar puncture procedure
Secondary outcomes:
measure: Percentage of Procedures With Post-dural Puncture Headache (PDPH)
timeFrame: The assessment during 7-day follow-up after each lumbar puncture procedure
measure: Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3
timeFrame: The laboratory analysis within 3 hours of the lumbar puncture
measure: Percentage of Procedures With Other Complications or Adverse Events
timeFrame: The assessment during 7-day and four-week follow ups
measure: Aggregate Sensitivity of CSF Detection
timeFrame: The assessment immediately following each lumbar puncture procedure
measure: Aggregate False Detection Rate of CSF Detection
timeFrame: The assessment immediately following each lumbar puncture procedure
measure: Number of Required Attempts Per Successful Lumbar Puncture Procedure
timeFrame: The assessment immediately following each lumbar puncture procedure
measure: Number of Failed Lumbar Puncture Procedures
timeFrame: The assessment immediately following each lumbar puncture procedure
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital, New Children's Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Sauli Palmu, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: