Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000354482p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
3D printed intranasal splint made with biomed flex 80A resin to investigate its safety and tolerability in healthy volunteers
Scientific title
Intranasal splint made with biomed flex 80A resin to investigate its safety and tolerability in healthy volunteers
Secondary ID [1] 312398 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nasal skin cancers 336867 0
Condition category
Condition code
Cancer 333456 333456 0 0
Non melanoma skin cancer
Surgery 333336 333336 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3D printed intranasal splint made with biomed flex 80A resin post skin graft reconstruction for nasal alar oncological defects. The device can be easily inserted into both nostrils and should sit in place without additional taping or supports. Participants will be advised to wear the splint for a total of 10 days continuously and advised to change to a new splint every 24 hours. Questionnaires using validated tools from the literature will be used to assess adherence to the intervention
Intervention code [1] 330665 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340911 0
Adverse events
Timepoint [1] 340911 0
day 6+/-1, day 14 +/-3, day 30 +/-3 post-commencement of intervention
Primary outcome [2] 341030 0
Tolerability of the device
Timepoint [2] 341030 0
day 6+/-1, day 14 +/-3, day 30 +/-3 post commencement of intervention
Secondary outcome [1] 445426 0
Medical device failure or defects (composite)
Timepoint [1] 445426 0
day 6+/-1, day 14 +/-3, day 30 +/-3 post commencement of intervention

Eligibility
Key inclusion criteria
Healthy unaffected volunteers from TRI (translational research institute) or PAH (Princess Alexandra Hospital). Healthy refers to individuals who do not have any significant past medical history especially relating to the nose, have not had surgery on their nose and are not due for any surgery or investigation related to their nose
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Age >80yrs or <18yrs
• Active smoking (at any quantity) or being an active smoker within the last 12 months
• Recent surgeries of the nose
• Previous surgical intervention significantly compromising the integrity of the nasal architecture in that a nasal packing/splinting technique is contra-indicated
• Use of the proposed medical device is contra-indicated for patient safety (i.e. due to patient allergies)
• unable to provide informed consent for participation in the trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318597 0
Government body
Name [1] 318597 0
Metro South Health
Country [1] 318597 0
Australia
Funding source category [2] 316806 0
Government body
Name [2] 316806 0
Princess Alexandra Hospital
Country [2] 316806 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
Country
Australia
Secondary sponsor category [1] 321093 0
None
Name [1] 321093 0
N/A
Address [1] 321093 0
Country [1] 321093 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315576 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315576 0
Ethics committee country [1] 315576 0
Australia
Date submitted for ethics approval [1] 315576 0
25/02/2025
Approval date [1] 315576 0
Ethics approval number [1] 315576 0

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

Contacts
Principal investigator
Name 135130 0
Dr Michael Wagels
Address 135130 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 135130 0
Australia
Phone 135130 0
+61 0406183619
Fax 135130 0
Email 135130 0
[email protected]
Contact person for public queries
Name 135131 0
Amy Yoon
Address 135131 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
Country 135131 0
Australia
Phone 135131 0
+61 0451817118
Fax 135131 0
Email 135131 0
[email protected]
Contact person for scientific queries
Name 135132 0
Amy Yoon
Address 135132 0
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102
Country 135132 0
Australia
Phone 135132 0
+61 0451817118
Fax 135132 0
Email 135132 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolN/A   Protocol - RCT Study - V2.docx


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.