ANZCTR - Registration

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

nasal skin cancers

Condition category

Condition code

Surgery

Surgical techniques

Cancer

Non melanoma skin cancer

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Adverse events

Timepoint [1]

day 6+/-1, day 14 +/-3, day 30 +/-3 post-commencement of intervention

Primary outcome [2]

Tolerability of the device

Timepoint [2]

day 6+/-1, day 14 +/-3, day 30 +/-3 post commencement of intervention

Secondary outcome [1]

Medical device failure or defects (composite)

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Princess Alexandra Hospital

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Metro South Health

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Metro South Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

https://metrosouth.health.qld.gov.au/research/about-us/hrec

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/02/2025

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to investigate the safety and tolerability of 3D printed intranasal splints in healthy participants.

Who is it for?
You may be eligible for this study if you are a healthy adult, without a history of surgeries to the nose.

Study details
All participants in this study will be asked to wear a splint in the nose continuously for 10 days and will be followed up for 30 days to see if there have been any side effects

It is hoped this study will help determine if these splints are safe to use for a future randomised trial looking at whether these devices can be helpful in nasal skin cancers

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Wagels

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 0406183619

Fax

[email protected]

Contact person for public queries

Name

Amy Yoon

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102

Country

Australia

Phone

+61 0451817118

Fax

[email protected]

Contact person for scientific queries

Name

Amy Yoon

Address

Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102

Country

Australia

Phone

+61 0451817118

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24583	Study protocol	N/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.

Trial Review

Documents added manually

Documents added automatically