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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-08

Study Completion Date

2020-10-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture

NCT02792660

Pediatric Lumbar Puncture

COMPLETED NA

Lumbar Puncture Stylet Technique in Children

NCT05009173

Traumatic Tap

UNKNOWN NA

Pediatric Lumbar Puncture Success Using the COMPASS

NCT01285531

Lumbar Puncture

UNKNOWN NA

Indocyanine Green (ICG) Guided Tumor Resection

NCT04084067

Neoplastic Disease Solid Tumor

RECRUITING PHASE1

Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

NCT05645523

Solid Tumor

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Puncture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IQ-Tip

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

Group Type EXPERIMENTAL

IQ-Tip(tm) system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IQ-Tip(tm) system

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No