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The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures — IQ-LP-03  

Lumbar Puncture Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04070144
Study type Interventional
Source Injeq Ltd
Contact
Status Completed
Phase N/A
Start date November 8, 2019
Completion date October 2, 2020
View Details
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