NCT04070144

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Injeq Ltd · Industry
• Sex: All
• Age: 18 Months – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lumbar Puncture

Interventions

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

Timeline

• Start date: 2019-11-08
• Primary completion: 2020-08-06
• Completion: 2020-10-02
• First posted: 2019-08-28
• Last updated: 2023-06-13
• Results posted: 2023-06-13

Locations

3 sites across 1 country: Finland