Pediatric Lumbar Puncture Clinical Trial
Official title:
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
NCT number | NCT02792660 |
Other study ID # | INJ-SPINE-02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | November 2018 |
Verified date | November 2018 |
Source | Injeq Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Months |
Eligibility |
Inclusion Criteria: - Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample. - Consent from the parents Exclusion Criteria: - Being a high risk patient (as determined by the investigator) - Any contraindication to a common lumbar puncture apply also in the investigation |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere | |
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Injeq Ltd |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | During lumbar puncture |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05302765 -
Intravenous Fluid Administration's Effect on Pediatric Lumbar Puncture
|
N/A |