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Trial registered on ANZCTR


Registration number
ACTRN12625000869471
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
11/08/2025
Date last updated
11/08/2025
Date data sharing statement initially provided
11/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Investigation on the Safety and Feasibility of Ablation in the Uterus
Scientific title
A Prospective Investigation on the Safety and Feasibility of Ablation for Adenomyosis
Secondary ID [1] 314711 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study of ACTRN12625000504415 for participants diagnosed with adenomyosis. 

Health condition
Health condition(s) or problem(s) studied:
Adenomyosis 337904 0
Condition category
Condition code
Reproductive Health and Childbirth 334234 334234 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research study is to assess the safety and feasibility of a new device designed for the ablation of uterine tissue. Subjects will have a procedure using a device that delivers energy to abnormal uterine tissue. The resected tissue will be analyzed to determine the characteristics of the energy applied to it. Qualified physicians will perform procedures in an operating room.

Subjects will undergo a procedure where a device which has an applicator will be used to deliver energy to the uterus from inside the body, in subjects undergoing ablation for a specific condition. Images obtained during the procedure will be analysed to understand characteristics of the energy delivered to the tissue. Procedures will occur in an operating room and will be performed by qualified physicians. The study procedure will last for approximately 2 hours. Participants will be followed up for 12 months following the procedure.
Intervention code [1] 331318 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341900 0
Early Performance
Timepoint [1] 341900 0
At 3- and 6-months post-procedure
Primary outcome [2] 341901 0
Safety
Timepoint [2] 341901 0
Intra-procedural and post-procedural SAEs through the 3-month follow-up period and Investigational Device or Study Procedure and device-related AEs through the 30-day follow-up period. Adverse Events will be graded using the Clavien-Dindo classification.
Secondary outcome [1] 448910 0
Nil
Timepoint [1] 448910 0
Nil

Eligibility
Key inclusion criteria
1. Female subject is greater than or equal to 22 years old at the time of consent.
2. Subject has MRI-determined diagnosis of adenomyosis
3. Subjects with a uterine size of up to 12cm and/or wall thickness of 6 cm.
4. Subject is within reproductive age or after reproductive age but not in menopause, as evaluated by the Investigator.
5. Subject is not seeking pregnancy after the Study Procedure or is unable to get pregnant due to anatomical or surgical reasons such as tubal ligation.
6. Subjects of child-bearing potential must not be pregnant as confirmed with a negative urine or serum beta human chorionic gonadotropin test prior to the index procedure, or lactating/breast-feeding.
Minimum age
22 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects contraindicated for surgery or general anesthesia.
2. Subjects who require emergent hysterectomy.
3. Subjects who have suspicion or confirmation of gynecologic malignancy as evidenced by endometrial biopsy and/or radiologic imaging.
4. Subjects who have fibroids in the proximity of the target adenomyosis.
5. Subjects who are not candidates for the Study Procedure as determined by the Investigator during pre-operative health assessment.
6. Subjects with concomitant disease, that, in the opinion of the Investigator, could interfere with the study, including but not limited to pelvic inflammatory disease, deep infiltrating endometriosis, multiple fibroids obscuring the myometrium or junctional zone, pelvic congestion syndrome, AP malformation, intrauterine adhesions, or ovarian endometrioma > three (3) cm.
7. Subject previously underwent endometrial ablation, uterine artery embolization, high-intensity focused ultrasound, myomectomy, or any other uterine-preserving technique for reduction of menstrual bleeding.
8. Subjects with an implantable uterine or fallopian tube device for contraception that is unable to be removed prior to the procedure.
9. Subject with ferromagnetic implants.
10. Subject with estimated glomerular filtration rate (eGFR) less than 30 and/or had previous reaction to gadolinium.
11. Subjects who have taken gonadotropin-releasing hormone (GnRH) agonist or antagonist medication within three (3) months prior to baseline visit.
13. Subjects with clinically significant electrocardiogram (ECG) findings such as new clinically significant arrythmia or conduction disturbances.
14. Subjects with presence of any implanted electronic devices (e.g., cardiac pacemakers or defibrillators) that cannot be turned off during the procedure.
15. Subjects with implanted electronic devices or implants with metal parts in the immediate vicinity of the treatment area.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Summary statistics for binary endpoints will include number and percentage and 95% Wilson confidence intervals where applicable. Continuous endpoints will be summarized descriptively, including (where applicable) by number, mean, median, standard deviation, interquartile range, and range. Where applicable, 95% confidence intervals will be provided.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28126 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 44332 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 319263 0
Commercial sector/Industry
Name [1] 319263 0
Ascend Clinical Research Organisation, Pty Ltd.
Country [1] 319263 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascend Clinical Research Organisation, Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 321737 0
None
Name [1] 321737 0
Address [1] 321737 0
Country [1] 321737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317842 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 317842 0
Ethics committee country [1] 317842 0
Australia
Date submitted for ethics approval [1] 317842 0
30/10/2024
Approval date [1] 317842 0
27/11/2024
Ethics approval number [1] 317842 0

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

Contacts
Principal investigator
Name 142326 0
Dr Danny Chou
Address 142326 0
St George Private Hospital 1 South St Kogarah, NSW, 2217, Australia
Country 142326 0
Australia
Phone 142326 0
+61 2 9587 3388
Fax 142326 0
Email 142326 0
[email protected]
Contact person for public queries
Name 142327 0
Dr Danny Chou
Address 142327 0
St George Private Hospital 1 South St Kogarah, NSW, 2217, Australia
Country 142327 0
Australia
Phone 142327 0
+61 2 9587 3388
Fax 142327 0
Email 142327 0
[email protected]
Contact person for scientific queries
Name 142328 0
Dr Danny Chou
Address 142328 0
St George Private Hospital 1 South St Kogarah, NSW, 2217, Australia
Country 142328 0
Australia
Phone 142328 0
+61 2 9587 3388
Fax 142328 0
Email 142328 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: IPD will not be available



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.