Pediatric Lumbar PunctureNCT02792660
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
A study testing Injeq IQ-Needle in people with Pediatric Lumbar Puncture, run by Injeq Ltd at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Pediatric Lumbar Puncture
- What is being tested?
- Injeq IQ-Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- Jul 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
- Consent from the parents
Who cannot join
- Being a high risk patient (as determined by the investigator)
- Any contraindication to a common lumbar puncture apply also in the investigation
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Tampere University Hospital
Tampere, FI-33521
Turku University Hospital
Turku, 20521
About this study
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.
- Conditions
- Pediatric Lumbar Puncture
- Being tested
- Injeq IQ-Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injeq IQ-NeedleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Injeq IQ-Needle | Experimental | Lumbar puncture is performed using Injeq IQ-Needle Receives: Device: Injeq IQ-Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Lumbar PunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Injeq Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vesa Eskola, PhD MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792660
- Sponsor's protocol ID
- INJ-SPINE-02
- Status last verified
- Nov 2018
- First submitted
- 2 Jun 2016
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
- ClinicalTrials.gov ID
- NCT02792660
- Acronym / sponsor ID
- INJ-SPINE-02
- Conditions
- Pediatric Lumbar Puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Injeq LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injeq IQ-Needle | Experimental | Device: Injeq IQ-NeedleLumbar puncture is performed using Injeq IQ-Needle |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
- Consent from the parents
Key exclusion criteria (2 listed)
- Being a high risk patient (as determined by the investigator)
- Any contraindication to a common lumbar puncture apply also in the investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injeq IQ-NeedleInjeq 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. | Device | Injeq IQ-Needle |
Primary outcome
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
Time frame: During lumbar puncture
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesa Eskola, PhD MD principal investigator
Tampere University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injeq IQ-Needle in people with Pediatric Lumbar Puncture, run by Injeq Ltd at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form (time frame: During lumbar puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.