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Trial registered on ANZCTR
Registration number
ACTRN12626001049369p
Ethics application status
Submitted, not yet approved
Date submitted
1/06/2026
Date registered
26/08/2026
Date last updated
26/08/2026
Date data sharing statement initially provided
26/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
A prospective pilot study of the safety and efficacy of thyroid artery embolisation (TAE) for the treatment of symptomatic thyroid nodular goitre
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Scientific title
A prospective pilot study of the safety and efficacy of thyroid artery embolisation (TAE) for the treatment of symptomatic thyroid nodular goitre
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Additional trial identifiers [1]
317449
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
The TAE Study
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Related trial records
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Health condition
Health condition(s) studied:
Symptomatic Thyroid Nodular Goitre
342148
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Condition category
Condition code
Metabolic and Endocrine
338263
338263
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0
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Thyroid disease
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The intervention is thyroid artery embolisation (TAE), a minimally invasive endovascular procedure used to treat symptomatic thyroid nodular goitre. The procedure is performed by a specialist interventional radiologist with expertise in embolisation techniques.
TAE is performed in an interventional radiology suite at The Alfred Hospital and typically takes approximately 60 minutes. Under local anaesthesia, a small catheter is inserted into an artery (typically via the wrist, arm, or groin) and guided to the thyroid arteries under X-ray guidance. Embolic agents, including polyvinyl alcohol (PVA) particles and emolisation coils, are then used to reduce blood flow to the thyroid nodule(s),
The procedure is usually performed as a day procedure, with patients observed for a minimum of 4 hours following treatment before discharge, provided they are clinically stable.
Follow-up assessments will be conducted by the study investigators at 2 weeks, 6 months, and 12 months following the procedure. Assessments include clinical review, thyroid function tests, imaging (ultrasound and CT), and completion of the ThyPRO-39 questionnaire. Attendance at follow-up visits will be supported through study team coordination and appointment reminders.
Fidelity to the intervention will be assessed through adherence to the study protocol, including use of approved embolic materials, documentation of the target vessels treated, embolisation endpoint achieved, procedural details, and completion of scheduled follow-up assessments.
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Intervention code [1]
334243
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Treatment: Devices
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Description of the comparator or control
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Safety, assessed as a composite outcome comprising the incidence and severity of procedural and post-procedural complications and adverse events.
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Assessment method [1]
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Assessed at the procedure, pre-discharge, 2 weeks, and 6 months using clinical review, physical examination, vital signs (blood pressure, heart rate and oxygen saturation measured using a multiparameter monitor), thyroid function tests, and imaging where clinically indicated. Adverse events and complications will be classified according to the CIRSE Classification System. Examples include neck pain, haematoma, access-site complications, voice changes, infection, thyroid dysfunction, and non-target embolisation.
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Timepoint [1]
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6 months TAE post-procedure
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Primary outcome [2]
345618
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Change in the thyroid-specific patient reported outcome
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Assessment method [2]
345618
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Assessed using the validated ThyPRO-39 questionnaire administered at baseline and 6-month follow-up.
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Timepoint [2]
345618
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6 months TAE post-procedure
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Secondary outcome [1]
462437
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Mean nodule volume reduction
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Assessment method [1]
462437
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Ultrasound and CT scan
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Timepoint [1]
462437
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6 months TAE post-procedure
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Eligibility
Key inclusion criteria
1. Adult patients greater than or equal to 18 years
2. Symptomatic Nodular Thyroid Disease (goitre)
3. Dominant nodule size greater than or equal to 30 cc or dominant nodule with retrosternal extension
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1. Thyroid malignancy
2. Iodine contrast allergy
3. Severe renal insufficiency
4. Aberrant arterial anatomy such that embolisation treatment to a sufficient endpoint would be unfeasible
5. Significant atherosclerotic disease such that embolisation treatment to a sufficient endpoint would be unfeasible
6. Severe cardiovascular or respiratory illness
7. Current pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
5
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
29562
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
45886
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
322022
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Hospital
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Name [1]
322022
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Radiology Department, Alfred Hospital
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Address [1]
322022
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Country [1]
322022
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Australia
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Primary sponsor type
Hospital
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Name
Bayside Health (Alfred Hospital)
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Address
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Country
Australia
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Secondary sponsor category [1]
324903
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None
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Name [1]
324903
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Address [1]
324903
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Country [1]
324903
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
320555
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
320555
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
320555
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Australia
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Date submitted for ethics approval [1]
320555
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03/06/2026
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Approval date [1]
320555
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Ethics approval number [1]
320555
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Summary
Brief summary
The authors aim to perform thyroid artery embolisation (TAE) for a pilot cohort of 5 patients with symptomatic benign thyroid nodules and/or thyroid goitre to determine the safety, feasibility, efficacy and outcomes in the local setting.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Matthew Lukies
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Address
150858
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Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
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Country
150858
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Australia
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Phone
150858
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+61 3 9076 2118
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Fax
150858
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Email
150858
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[email protected]
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Contact person for public queries
Name
150859
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Adil Zia
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Address
150859
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Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
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Country
150859
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Australia
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Phone
150859
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+61 3 9076 2126
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Fax
150859
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Email
150859
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[email protected]
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Contact person for scientific queries
Name
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Adil Zia
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Address
150860
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Alfred Hospital, 55 Commercial Road, Melbourne, Victoria 3004
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Country
150860
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Australia
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Phone
150860
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+61 3 9076 2126
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Fax
150860
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Email
150860
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
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.
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