Trial Outcomes & Findings for The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures (NCT NCT04070144)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

The assessment immediately following each lumbar puncture procedure

Results posted on

2023-06-13

Participant Flow

Unit of analysis: lumbar puncture

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	50 152
Overall Study COMPLETED	50 152
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IQ-Tip n=152 lumbar puncture 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
Age, Continuous	7.1 years n=50 Participants
Sex: Female, Male Female	23 Participants n=50 Participants
Sex: Female, Male Male	27 Participants n=50 Participants
Height	123 cm n=50 Participants
Weight	29 kg n=50 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 Lumbar puncture 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
The First Puncture Success Rate	79.5 percentage of procedures Interval 72.1 to 85.6

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 Lumbar puncture 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
Rate of Serious Adverse Events	0 SAEs

SECONDARY outcome

Timeframe: The assessment during 7-day follow-up after each lumbar puncture procedure

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.

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 Lumbar puncture 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
Percentage of Procedures With Post-dural Puncture Headache (PDPH)	6 percentage of procedures

SECONDARY outcome

Timeframe: The laboratory analysis within 3 hours of the lumbar puncture

Population: A CSF sample was successfully obtained in 150 out of 152 lumbar puncture procedures

Erythrocyte (red blood cell) count according to laboratory analysis in units of 10\^6/liter or 1/mm3

Outcome measures

Outcome measures
Measure	IQ-Tip n=150 CSF sample 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
Percentage of CSF Samples With Greater or Equal to 10 Erythrocytes / mm^3	17.3 percentage of CSF samples Interval 11.7 to 24.4

SECONDARY outcome

Timeframe: The assessment during 7-day and four-week follow ups

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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 lumbar puncture 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
Percentage of Procedures With Other Complications or Adverse Events Nausea	15 percentage of procedures
Percentage of Procedures With Other Complications or Adverse Events Headache	14 percentage of procedures
Percentage of Procedures With Other Complications or Adverse Events Backache	14 percentage of procedures
Percentage of Procedures With Other Complications or Adverse Events Fever	7 percentage of procedures

SECONDARY outcome

Timeframe: The assessment immediately following each lumbar puncture procedure

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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 lumbar puncture 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
Aggregate Sensitivity of CSF Detection	86.1 percentage of succesfull procedures Interval 79.2 to 91.4

SECONDARY outcome

Timeframe: The assessment immediately following each lumbar puncture procedure

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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 lumbar puncture 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
Aggregate False Detection Rate of CSF Detection	9.2 percentage of procedures Interval 5.1 to 15.0

SECONDARY outcome

Timeframe: The assessment immediately following each 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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 lumbar puncture 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
Number of Required Attempts Per Successful Lumbar Puncture Procedure	1.3 lumbar puncture attempt Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: The assessment immediately following each lumbar puncture procedure

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

Outcome measures

Outcome measures
Measure	IQ-Tip n=152 lumbar puncture 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
Number of Failed Lumbar Puncture Procedures	1 failed procedure

Adverse Events

IQ-Tip

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IQ-Tip n=50 participants at risk 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
Musculoskeletal and connective tissue disorders Various aches	10.0% 5/50 • Number of events 5 • 4 weeks after a lumbar puncture procedure 4 week follow-up from the hospital records
Gastrointestinal disorders vomitting / nausea	12.0% 6/50 • Number of events 6 • 4 weeks after a lumbar puncture procedure 4 week follow-up from the hospital records

Additional Information

Chief Scientific Officer

Injeq

Phone: +358405805944‬

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place