Lumbar PunctureIQ-LP-03NCT04070144
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
A study testing IQ-Tip(tm) system in people with Lumbar Puncture, run by Injeq Ltd at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Lumbar Puncture
- What is being tested?
- IQ-Tip(tm) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFinland
- Study dates
- 8 Nov 2019to 2 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital, New Children's Hospital
Helsinki
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
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.
Read the 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 enables the real-time bioimpedance measurement at the tip of the needle. The needle is connected to the analyzer device, which provides real-time CSF detection during lumbar puncture from the very tip of the needle and by these means assists conducting the medical procedure.
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.
The investigation is conducted in the pediatric hematology and oncology units of three Finnish university hospitals
- Conditions
- Lumbar Puncture
- Being tested
- IQ-Tip(tm) system
- Keywords
- Spinal puncture, Lumbar puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQ-Tip(tm) systemDevice
Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system
| Study group | Role | What they receive |
|---|---|---|
| IQ-Tip | Experimental | At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant Receives: Device: IQ-Tip(tm) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: The assessment during four-week follow-up after each lumbar puncture procedure
Secondary outcomes (7)
Percentage of Procedures With Post-dural Puncture Headache (PDPH)
PDPH defined as headache that:
- worsens in sitting or standing position
- eases when lying down
- occurs within 7 days after the lumbar puncture procedure
Possible symptoms are recording using a diary filled by the patient or parents and verified by the study nurse.
Measured: 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
Erythrocyte (red blood cell) count according to laboratory analysis in units of 10^6/liter or 1/mm3
Measured: The laboratory analysis within 3 hours of the lumbar puncture
Percentage of Procedures With Other Complications or Adverse Events
E.g. PDPH or backache
Possible symptoms are recorded using a diary filled by the patient or parents and verified by the study nurse. Diary is an open questionaire that is intended for recording any possible complication. Possible complications are not considered as pre-determined outcome measures, with the exception of Outcome #3 (rate of PDPH)
Four-week follow up conducted by the study nurse from the hospital registers
Measured: The assessment during 7-day and four-week follow ups
Aggregate Sensitivity of CSF Detection
The CSF detection performance of the investigational device is assessed by the physician.
Each individual lumbar puncture procedure is classified as either 'True Positive CSF detection (TP)', 'False Negative CSF detection (FN)' or 'Procedure failed (Fail)' by the investigator.
The aggregate sensitivity = Number of TPs / Total number of procedures
Measured: The assessment immediately following each lumbar puncture procedure
Aggregate False Detection Rate of CSF Detection
Each individual lumbar puncture procedure is classified as either 'One or more False Positive CSF detections (FP)' or 'No False Positive CSF detections (TN)'.
The aggregate false detection rate = Number of FPs / Total number of procedures
Measured: The assessment immediately following each lumbar puncture procedure
Number of Required Attempts Per Successful Lumbar Puncture Procedure
In line with definition of 'the first puncture success rate', attempt is defined as: any new penetration of skin is considered a new attempt.
Lumbar puncture is considered successful irrespective of the number of punctures if the CSF sample was eventually obtained and/or the injection of medicine could be performed
Measured: The assessment immediately following each lumbar puncture procedure
Number of Failed Lumbar Puncture Procedures
Procedure is considered failed if physicians, even after multiple attempts, conclude that the lumbar puncture cannot be completed with available personnel or equipment due to any reason
Measured: The assessment immediately following each lumbar puncture procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start8 Nov 2019
- Primary completion6 Aug 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Injeq Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sauli Palmu, PhD MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070144
- Sponsor's protocol ID
- IQ-LP-03
- Acronym
- IQ-LP-03
- Status last verified
- Jun 2023
- First submitted
- 23 Aug 2019
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
- ClinicalTrials.gov ID
- NCT04070144
- Acronym / sponsor ID
- IQ-LP-03 / IQ-LP-03
- Conditions
- Lumbar Puncture
- Keywords
- Spinal puncture, Lumbar puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Injeq LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 enables the real-time bioimpedance measurement at the tip of the needle. The needle is connected to the analyzer device, which provides real-time CSF detection during lumbar puncture from the very tip of the needle and by these means assists conducting the medical procedure.
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.
The investigation is conducted in the pediatric hematology and oncology units of three Finnish university hospitals
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IQ-Tip | Experimental | Device: IQ-Tip(tm) systemAt most four lumbar punctures with Injeq IQ-Tip(tm) system per participant |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| IQ-Tip(tm) systemPhysician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system | Device | IQ-Tip |
Primary outcome
The First Puncture Success Rate
Time frame: The assessment immediately following each lumbar puncture procedure
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
Rate of Serious Adverse Events
Time frame: The assessment during four-week follow-up after each lumbar puncture procedure
Total number of serious adverse events caused by the device. Serious adverse event in probable or causal relationship to the investigational device exposure
7 secondary outcomes
Percentage of Procedures With Post-dural Puncture Headache (PDPH)
Time frame: 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
Time frame: The laboratory analysis within 3 hours of the lumbar puncture
Percentage of Procedures With Other Complications or Adverse Events
Time frame: The assessment during 7-day and four-week follow ups
Aggregate Sensitivity of CSF Detection
Time frame: The assessment immediately following each lumbar puncture procedure
Aggregate False Detection Rate of CSF Detection
Time frame: The assessment immediately following each lumbar puncture procedure
Number of Required Attempts Per Successful Lumbar Puncture Procedure
Time frame: The assessment immediately following each lumbar puncture procedure
Number of Failed Lumbar Puncture Procedures
Time frame: The assessment immediately following each lumbar puncture procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sauli Palmu, PhD MD principal investigator
Tampere University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQ-Tip(tm) system in people with Lumbar Puncture, run by Injeq Ltd at 3 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The First Puncture Success Rate (time frame: The assessment immediately following each lumbar puncture procedure). The study lists 2 primary outcomes in all. 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 13 Jun 2023.