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

Injeq

Status: Completed

Conditions: Lumbar Puncture

Treatments: Device: IQ-Tip(tm) system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04070144

IQ-LP-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

IQ-Tip

Experimental group

Description:

At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant

Treatment:

Device: IQ-Tip(tm) system