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

NCT04070144 | Completed Results

• 1 other identifier: IQ-LP-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lumbar Puncture

Keywords

Spinal puncture; Lumbar puncture

Outcome Measures

Primary Outcomes (2)

• The First Puncture Success Rate

  Each individual lumbar puncture procedure is assessed as either 'first puncture success' or '-failure'. Success rate = Successes / All procedures Definition of the first puncture success: * Only one skin puncture with the needle is allowed; * Multiple stylet removals and reinsertions are allowed; * Multiple needle reorientations are allowed as long as needle tip remains inside the skin; * Physician must be able obtain a cerebrospinal fluid (CSF) sample that is sent to a laboratory analysis or to inject the intended medication to the patient's subarachnoid space; and * Physician conducting the puncture remains the same during the procedure

  The assessment immediately following each lumbar puncture procedure

• Rate of Serious Adverse Events

  Total number of serious adverse events caused by the device. Serious adverse event in probable or causal relationship to the investigational device exposure

  The assessment during four-week follow-up after each lumbar puncture procedure

Secondary Outcomes (7)

• Percentage of Procedures With Post-dural Puncture Headache (PDPH)

  The assessment during 7-day follow-up after each lumbar puncture procedure

• Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3

  The laboratory analysis within 3 hours of the lumbar puncture

• Percentage of Procedures With Other Complications or Adverse Events

  The assessment during 7-day and four-week follow ups

• Aggregate Sensitivity of CSF Detection

  The assessment immediately following each lumbar puncture procedure

• Aggregate False Detection Rate of CSF Detection

  The assessment immediately following each lumbar puncture procedure

Study Arms (1)

IQ-Tip

EXPERIMENTAL

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

Device: IQ-Tip(tm) system

Interventions

IQ-Tip(tm) system DEVICE

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

IQ-Tip

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Injeq Ltd: lead

Study Sites (3)

Helsinki University Hospital, New Children's Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Injeq

info@injeq.com

+358405805944‬

Study Officials

• Sauli Palmu, PhD MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: November 8, 2019
• Primary Completion: August 6, 2020
• Study Completion: October 2, 2020
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)