Status:
COMPLETED
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
Lead Sponsor:
Injeq Ltd
Conditions:
Lumbar Puncture
Eligibility:
All Genders
18-18 years
Phase:
NA
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 ped...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04070144
Start Date
November 8 2019
End Date
October 2 2020
Last Update
June 13 2023
Active Locations (3)
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1
Helsinki University Hospital, New Children's Hospital
Helsinki, Finland
2
Tampere University Hospital
Tampere, Finland
3
Turku University Hospital
Turku, Finland