An interventional study of Injeq IQ-Needle in Pediatric Lumbar Puncture, sponsored by Injeq Ltd. Completed at 2 sites in Finland. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by Injeq Ltd · Not applicable, Interventional, and Other
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 40 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
Lumbar puncture is performed using Injeq IQ-Needle
Device: Injeq IQ-Needle
Injeq IQ-Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect CSF, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the lumbar puncture and were the detections true or false detections.
Time frame: During lumbar puncture
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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