N/A
N=50
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Lumbar Puncture
Bottom Line
View on ClinicalTrials.gov: NCT04070144 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The First Puncture Success Rate — 79.5 percentage of procedures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IQ-Tip(tm) system (Device)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Injeq Ltd
- Primary completion
- Aug 2020
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 | — |
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.
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.