Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000415404p
Ethics application status
Not yet submitted
Date submitted
23/04/2025
Date registered
7/05/2025
Date last updated
7/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability of the multi-jet injection technique
Scientific title
Assessing pain and acceptability of multi-jet injection in healthy volunteers
Secondary ID [1] 314052 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer immunotherapy delivery 336799 0
Condition category
Condition code
Cancer 333292 333292 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will recieve one 'multi-jet injection' intervention and one control intervention.

Multi-jet injection involves the delivery of a fluid (in this case isotonic saline) as multiple simultaneous high speed jets. The jets are small (0.2 mm or less) and travelling fast enough (>120 m/s) that they can break through the skin layers and deliver themselves to the subcutaneous or intramuscular tissue. In this study participants will recieve a multi-jet injection in the abdomen region performed by a nurse that has been trained to use a multi-jet injector. The injection will take <1 s. Pain will be measured using a 100 mm visual analogue scale ~30 seconds after and 1 day after the injections. Participants will also be asked whether they preferred the multi-jet or control intervention after both are completed (at least 5 mins after the final injection) and again 1-day after the injections. A nurse will also record the existence of any injection site reactions (redness, swelling, bleeding, or bruising) immediately after and 1 day after the injections. The investigators will also note any evidence of the fluid remaining on the skin surface, or otherwise failing to inject. The order and location (left or right side of the abdomen) of the interventions will be randomised with a break of at least 2 minutes between the interventions. The interventions will take place at a clinical trial facility within the University of Auckland (Grafton, Auckland, NZ). A 1 hour visit will be required to conduct the interventions then the participants will be asked to complete a questionnaire (via email) 24hrs after the interventions.

We will assess multi-jet injection both needle-free, where only the liquid jets themselves penetrate the skin, and 'micro-needle assisted' where the jets are formed through small microneedles. The microneedles are very short (<1 mm exposed length) 30G needles that penetrate through the epidermis, the jets formed through the hollow bore of the microneedles then penetrate into the subcutaneous fat or intramuscur layer. In both the needle-free and microneedle multi-jet injections we will inject the isotonic saline as seven simultaneous jets.

Participants will be randomly allocated into one of five groups (listed below), allowing us to study the effect of injection volume and the use of microneedles to assist the jets penetration through the epidermis.
Arm 1: Needle-free 2 mL
Arm 2: Microneedle 2 mL
Arm 3: Needle-free 4 mL
Arm 4: Microneedle 4 mL
Arm 5: Microneedle 6 mL
Intervention code [1] 330633 0
Treatment: Devices
Comparator / control treatment
Each participant will recieve a control intervention which will involve standard subcutaneous injection(s) with a 25G hypodermic needle and syringe. The control intervention will match the volume of the multi-jet injection intervention. For the 4 mL and 6 mL groups the volume exceeds the typical limit for subcutaneous delivery so the control intervention will be performed over multiple subsequent injections (2x2 mL injections in the 4 mL groups, 3x 2mL injections in the 6 mL group). When multiple injections are performed each will be injected ~1 cm away from the previous injection site. A nurse will perform all injections with each 2 mL injection performed over 30 s. Injections will be administered to the abdomen with the control and multi-jet interventions on opposite sides of the body. The side and order of interventions will be randomised.
Control group
Active

Outcomes
Primary outcome [1] 340883 0
Pain
Timepoint [1] 340883 0
Timepoint 1: ~30 seconds post intervention, Timepoint 2: 1 day post interventions.
Primary outcome [2] 340884 0
Intervention preference (control versus multi-jet)
Timepoint [2] 340884 0
Timepoint 1: 5 minutes after the final intervention, answer provided verbally. Timepoint 2: 1 day after interventions, answer provided via written/digital questionaire.
Secondary outcome [1] 445342 0
Delivery success
Timepoint [1] 445342 0
During the intervention and the ~1minute following intevention completion.
Secondary outcome [2] 445343 0
Injection site reactions
Timepoint [2] 445343 0
Timepoint 1: immediately after intervention. Timepoint 2: 1 day after the injections. At timepoint 1 the nurse will directly observe the injection site, at timepoint 2 a photograph will be taken of the injection site.

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Needle-phobia
Clotting disorders
Carriers of communicable disease (eg. HIV)
Low body-mass index (<18.5)
Individuals who regularly inject themselves in the abdomen region (eg. diabetics)
Pregnancy
Inability to provide informed consent (eg. neurological impairment)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using computer-based random number generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computational random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A total of 40 participants will be recruited (8 in each of the five groups). We estimate that at this sample size we will be able to detect a difference in the mean pain score between multi-jet injection and the control of as small as 8 units (assuming alpha=0.05, beta=20%, and standard deviation of pain scores of 13 units). When examining the effect of injection volume and needle-free vs microneedle assisted multi-jet injection we expect to be able to detect a difference in the mean pain scores between groups of as low as 15 units.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
28/02/2027
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26918 0
New Zealand
State/province [1] 26918 0
Auckland

Funding & Sponsors
Funding source category [1] 318558 0
Self funded/Unfunded
Name [1] 318558 0
Country [1] 318558 0
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320956 0
None
Name [1] 320956 0
Address [1] 320956 0
Country [1] 320956 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317158 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317158 0
Ethics committee country [1] 317158 0
New Zealand
Date submitted for ethics approval [1] 317158 0
31/07/2025
Approval date [1] 317158 0
Ethics approval number [1] 317158 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140198 0
Dr James McKeage
Address 140198 0
Auckland Bioengineering Institute, University of Auckland, Level 6, 70 Symonds Street, Grafton, Auckland
Country 140198 0
New Zealand
Phone 140198 0
+64 9 923 3175
Fax 140198 0
Email 140198 0
[email protected]
Contact person for public queries
Name 140199 0
James McKeage
Address 140199 0
Auckland Bioengineering Institute, University of Auckland, Level 6, 70 Symonds Street, Grafton, Auckland
Country 140199 0
New Zealand
Phone 140199 0
+64 9 923 3175
Fax 140199 0
Email 140199 0
[email protected]
Contact person for scientific queries
Name 140200 0
James McKeage
Address 140200 0
Auckland Bioengineering Institute, University of Auckland, Level 6, 70 Symonds Street, Grafton, Auckland
Country 140200 0
New Zealand
Phone 140200 0
+64 9 923 3175
Fax 140200 0
Email 140200 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24654Study protocol  [email protected] Protocol (Extended study description) .pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.