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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQ-Tip | Experimental | At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQ-Tip(tm) system | Device | Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 | The assessment during four-week follow-up after each lumbar puncture procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Procedures With Post-dural Puncture Headache (PDPH) | PDPH defined as headache that:
Possible symptoms are recording using a diary filled by the patient or parents and verified by the study nurse. | The assessment during 7-day follow-up after each lumbar puncture procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sauli Palmu, PhD MD | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, New Children's Hospital | Helsinki | Finland | ||||
| Tampere University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | IQ-Tip | At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant IQ-Tip(tm) system: Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IQ-Tip | At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant IQ-Tip(tm) system: Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Number | 95% Confidence Interval | percentage of procedures | The assessment immediately following each lumbar puncture procedure | Lumbar puncture | Lumbar puncture |
|
4 weeks after a lumbar puncture procedure
4 week follow-up from the hospital records
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IQ-Tip | At most four lumbar punctures with Injeq IQ-Tip(tm) system per participant IQ-Tip(tm) system: Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Various aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | head, back, stomach or limbache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Injeq | +358405805944 | info@injeq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2020 | Apr 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 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 | 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 | 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 | 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 | 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 | 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 | The assessment immediately following each lumbar puncture procedure |
| Tampere |
| Finland |
| Turku University Hospital | Turku | Finland |
| lumbar puncture |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Height | Mean | Full Range | cm | Participants |
|
|
| Weight | Mean | Full Range | kg | Participants |
|
|
|
|
| Primary | 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 | Posted | Number | SAEs | The assessment during four-week follow-up after each lumbar puncture procedure | Lumbar puncture | Lumbar puncture |
|
|
|
| Secondary | Percentage of Procedures With Post-dural Puncture Headache (PDPH) | PDPH defined as headache that:
Possible symptoms are recording using a diary filled by the patient or parents and verified by the study nurse. | Posted | Number | percentage of procedures | The assessment during 7-day follow-up after each lumbar puncture procedure | Lumbar puncture | Lumbar puncture |
|
|
|
| Secondary | 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 | A CSF sample was successfully obtained in 150 out of 152 lumbar puncture procedures | Posted | Number | 95% Confidence Interval | percentage of CSF samples | The laboratory analysis within 3 hours of the lumbar puncture | CSF sample | CSF sample |
|
|
|
| Secondary | 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 | Posted | Number | percentage of procedures | The assessment during 7-day and four-week follow ups | lumbar puncture | lumbar puncture |
|
|
|
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of succesfull procedures | The assessment immediately following each lumbar puncture procedure | lumbar puncture | lumbar puncture |
|
|
|
| Secondary | 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 | Posted | Number | 95% Confidence Interval | percentage of procedures | The assessment immediately following each lumbar puncture procedure | lumbar puncture | lumbar puncture |
|
|
|
| Secondary | 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 | Posted | Mean | Full Range | lumbar puncture attempt | The assessment immediately following each lumbar puncture procedure | lumbar puncture | lumbar puncture |
|
|
|
| Secondary | 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 | Posted | Number | failed procedure | The assessment immediately following each lumbar puncture procedure | lumbar puncture | lumbar puncture |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 7 |
| 50 |
|
| vomitting / nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|
|
| Fever |
|