N/A
Completed N=50
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Lumbar Puncture
Source: ClinicalTrials.gov NCT04070144 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: The First Puncture Success Rate — 79.5 percentage of procedures
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Puncture Success Rate |
79.5 | — |
| PRIMARY Rate of Serious Adverse Events |
— | — |
| SECONDARY Percentage of Procedures With Post-dural Puncture Headache (PDPH) |
6 | — |
| SECONDARY Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3 |
17.3 | — |
| SECONDARY Percentage of Procedures With Other Complications or Adverse Events |
15; 14; 14; 7 | — |
| SECONDARY Aggregate Sensitivity of CSF Detection |
86.1 | — |
| SECONDARY Aggregate False Detection Rate of CSF Detection |
9.2 | — |
| SECONDARY Number of Required Attempts Per Successful Lumbar Puncture Procedure |
1.3 | — |
| SECONDARY Number of Failed Lumbar Puncture Procedures |
1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04070144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.