Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000504415
Ethics application status
Approved
Date submitted
31/01/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Retrospectively 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] 313831 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenomyosis 336477 0
Condition category
Condition code
Reproductive Health and Childbirth 332992 332992 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 undergo a procedure where a device which has an applicator will be used to deliver energy to the uterus from inside the body, immediately prior to a planned, elective benign hysterectomy. Tissue extracted during the planned resection 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 30 minutes. Participants will be followed up approximately 30 days following the procedure.

Details of the intervention ingredients will be provided on the ANZCTR registry at the end of IP assessment.
Intervention code [1] 330418 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340531 0
Feasibility
Timepoint [1] 340531 0
Post-operative
Primary outcome [2] 340532 0
Safety
Timepoint [2] 340532 0
daily up to the 30-day follow-up visit
Secondary outcome [1] 444354 0
Nil
Timepoint [1] 444354 0
Nil

Eligibility
Key inclusion criteria
1. Female subject is greater than or equal to 22 years old at the time consent.
2. Subject is planning to undergo elective hysterectomy for a benign gynaecologic condition.
Minimum age
22 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who require emergent hysterectomy.
2. Subjects who are not surgical candidates as determined by the Investigator during pre-operative health assessment.
3. Subjects who have suspicion or confirmation of gynaecologic malignancy as evidenced by endometrial biopsy and/or radiologic imaging.
4. Subjects with clinically significant electrocardiogram (ECG) findings such as new clinically significant arrythmia or conduction disturbances.
5. Subjects with presence of any implanted electronic devices that cannot be turned off during the procedure.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27558 0
St George Private Hospital - Kogarah
Recruitment postcode(s) [1] 43672 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 318302 0
Commercial sector/Industry
Name [1] 318302 0
Ascend Clinical Research Organization, Pty Ltd.
Country [1] 318302 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascend Clinical Research Organization, Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 320686 0
None
Name [1] 320686 0
Address [1] 320686 0
Country [1] 320686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316938 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 316938 0
Ethics committee country [1] 316938 0
Australia
Date submitted for ethics approval [1] 316938 0
30/10/2024
Approval date [1] 316938 0
27/11/2024
Ethics approval number [1] 316938 0

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

Contacts
Principal investigator
Name 139490 0
Dr Danny Chou
Address 139490 0
St George Private Hospital 1 South St Kogarah, NSW, 2217, Australia
Country 139490 0
Australia
Phone 139490 0
+61 2 9587 3388
Fax 139490 0
Email 139490 0
[email protected]
Contact person for public queries
Name 139491 0
Dr Michael Talbot
Address 139491 0
St George Private Hospital, Suite 3, Level 5, 1 South St, Kogarah NSW 2217
Country 139491 0
Australia
Phone 139491 0
+61 2 9553 1120
Fax 139491 0
Email 139491 0
[email protected]
Contact person for scientific queries
Name 139492 0
Dr Michael Talbot
Address 139492 0
St George Private Hospital, Suite 3, Level 5, 1 South St, Kogarah NSW 2217
Country 139492 0
Australia
Phone 139492 0
+61 2 9553 1120
Fax 139492 0
Email 139492 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.