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Trial registered on ANZCTR


Registration number
ACTRN12625000009415p
Ethics application status
Submitted, not yet approved
Date submitted
1/12/2024
Date registered
8/01/2025
Date last updated
8/01/2025
Date data sharing statement initially provided
8/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the cost of single use with reusable outpatient hysteroscopy.
Scientific title
Single use compared with reusable outpatient hysteroscopy: a randomised trial and cost effectiveness study
Secondary ID [1] 313478 0
Nil known
Universal Trial Number (UTN)
U1111-1316-2586
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Equity in access to outpatient procedures 335890 0
Abnormal uterine bleeding 335924 0
Condition category
Condition code
Reproductive Health and Childbirth 332473 332473 0 0
Other reproductive health and childbirth disorders
Public Health 332594 332594 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being examined is the use of a single use compared with a reusable hysteroscope in the context of outpatient diagnostic hysteroscopy procedures.

Participants will be recruited from the outpatient hysteroscopy service prior to or on the day of planned procedure. After screening the medical record ensuring conditions of inclusion and exclusion criteria are met, a member of the research team or clinician will gain informed consent from the participant and complete the enrolment form. Once enrolled in the study and after consent, participants will be randomly allocated 1:1 to have outpatient hysteroscopy using the single use device or conventional outpatient hysteroscopy. The procedure will be performed by a consultant gynaecologist from the Endosurgery Unit or a RANZCOG trainee level 5 or above who has performed at least 10 outpatient hysteroscopies in the preceding 12 months. Hysteroscopy will be performed using either conventional hysteroscopic device or single use device using a vaginoscopic approach where the hysteroscope is passed through the vagina and into the cervical canal using normal saline as distension medium. If a vaginoscopic technique is unsuccessful, local anaesthetic spray to the cervix or injection for intracervical or paracervical block may be administered to allow cervical dilatation for access the cavity. The findings at hysteroscopy are documented with intraoperative photographs. Any additional procedures such as removal of an endometrial polyp, endometrial sampling or an intrauterine device (IUD) insertion may be performed once hysteroscope is complete. Information for any operative procedure, sampling or IUD insertion will not be analysed for the purpose of this study, only the information for the diagnostic hysteroscopy procedure will be assessed. The procedure takes approximately 5-10 minutes.

For patients allocated to have their procedure with a single use hysteroscope, this will be performed with LiNA OperaScope. The LiNA OperaScope is a single-use, battery operated hysteroscopy device with a Liquid-crystal (LCD) display. It comes in a sterilised set with separate instruments available for biopsy and polyp removal available. A recording module can use used alongside the hysteroscope to allow for image capture and video recording of the procedure.

An operative report is documented for every procedure performed. For the purposes of the study, an audit of all reusable and disposable items will be recorded.
Intervention code [1] 330053 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator for the single use device is a reusable outpatient hysteroscope.

If patients are allocated to conventional outpatient hysteroscopy, hysteroscopy will be performed utilising a reusable 3mm scope with a 4mm sheath, reusable camera and light lead which connect to a stack with a recording module. The procedure will be performed as described in the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 340033 0
To determine the rate of successful outpatient diagnostic hysteroscopy access using a single use device to compare with our known success rate using the reusable set up
Timepoint [1] 340033 0
At the conclusion of the study.
Primary outcome [2] 340034 0
To calculate the difference in cost between single use vs reusable hysteroscopy device when modelled for a unit performing 6 hysteroscopes per month for 1 year.
Timepoint [2] 340034 0
An audit of all items and costs will be gathered at the time of the procedure
Secondary outcome [1] 442410 0
To evaluate the set-up of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [1] 442410 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.
Secondary outcome [2] 442411 0
To assess patient acceptability of utilising single use hysteroscope compared with conventional outpatient hysteroscopy
Timepoint [2] 442411 0
Patient scores will be gathered at the completion of the procedure.
Secondary outcome [3] 442771 0
To evaluate the image quality of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [3] 442771 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.
Secondary outcome [4] 442772 0
To evaluate the entry of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [4] 442772 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.
Secondary outcome [5] 442773 0
To evaluate the advancing and navigation of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [5] 442773 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.
Secondary outcome [6] 442774 0
To evaluate the view of the cavity of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [6] 442774 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.
Secondary outcome [7] 442775 0
To evaluate the overall ease of use of the single use hysteroscope compared with conventional outpatient hysteroscopy as assessed by the clinician
Timepoint [7] 442775 0
Clinician feedback will be obtained by a clinician questionnaire completed at the completion of the procedure.

Eligibility
Key inclusion criteria
• Age 18 years or above
• Planned outpatient hysteroscopy
• Patient consent
• English speakers
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Planned operative hysteroscopic procedure for myomectomy or large polypectomy (when procedure is planned to commence with operative scope and Myosure XL)
• Symptoms of or confirmed infection
• Pregnancy
• Previous failed outpatient hysteroscopic access
• Previous vasovagal reaction with cervical procedures or outpatient hysteroscopy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once a participant is enrolled in the study, they will be randomised via the RedCap module to either the single use or reusable group. Allocation will be concealed by a computerised central randomisation system in RedCap so that the enrolling clinician will not have access to the randomisation sequence. Once randomised, the clinician performing the hysteroscopy will be advised of the allocation for the participant via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created using a module within RedCap by a member of the study team who will not be performing participant recruitment. This allocation sequence will be utilised within RedCap to allocate participants to either arm of the study once recruited.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Procedure success rate will be reported as a proportion of total recruitment numbers (rate). Other demographic data, procedural information, patient and clinician survey data will be reported as univariate analysis using proportions (rates) and continuous variables reported with means (standard deviations).
If clinical equivalence is not demonstrated, no further evaluation will take place. If clinical equivalence is demonstrated, the data from the evaluation will be used to populate a cost-effectiveness model. The base case for the model is a hypothetical small gynaecological unit performing 72 outpatient hysteroscopies per year, six every month. Costs will be calculated from the hospital perspective and include costs of setup, individual procedure costs and any post-procedure device sterilisation required. In addition, for a failed procedure, the cost of an inpatient hysteroscopic procedure will be added. Effectiveness will be modelled using a combined patient and clinician rating of the procedure. The time horizon for the model will be set at one year, no discounting will be required due to the relatively short time horizon. Treeage software will be used to develop and run the model. All model inputs will be varied in sensitivity analysis to address potential for uncertainty.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27371 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 43465 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 317920 0
Charities/Societies/Foundations
Name [1] 317920 0
Normal Beischer Medical Research Foundation
Country [1] 317920 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
Country
Australia
Secondary sponsor category [1] 320264 0
None
Name [1] 320264 0
Address [1] 320264 0
Country [1] 320264 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316605 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 316605 0
https://www.mercyhealth.com.au/our-organisation/research/human-research-ethics-committee-hrec/
Ethics committee country [1] 316605 0
Australia
Date submitted for ethics approval [1] 316605 0
27/11/2024
Approval date [1] 316605 0
Ethics approval number [1] 316605 0

Summary
Brief summary
Outpatient hysteroscopy stands out as a safe, effective, and well-tolerated modality for investigating and treating intrauterine pathology. However, despite its advantages, outpatient hysteroscopy accounts for less than 0.5% of all hysteroscopies performed in Australia, largely due to the prohibitive upfront capital costs associated with setting up these services. This study aims to overcome this barrier by evaluating the LiNA OperaScope, an innovative all-in-one single-use hysteroscope device, to determine its patient and clinician acceptability and its cost-effectiveness compared to traditional methods. We hypothesise that single use hysteroscopy will be comparable to reusable hysteroscopy in effectiveness and may provide a most cost-effective option for clinicians to offer outpatient hysteroscopy to their patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138390 0
Dr Lucy Richards
Address 138390 0
c/o Mercy Hospital for Women, 163 Studley Rd, Heidelberg, VIC 3084
Country 138390 0
Australia
Phone 138390 0
+61 417427424
Fax 138390 0
Email 138390 0
[email protected]
Contact person for public queries
Name 138391 0
Lucy Richards
Address 138391 0
c/o Mercy Hospital for Women, 163 Studley Rd, Heidelberg, VIC 3084
Country 138391 0
Australia
Phone 138391 0
+61 417427424
Fax 138391 0
Email 138391 0
[email protected]
Contact person for scientific queries
Name 138392 0
Lucy Richards
Address 138392 0
c/o Mercy Hospital for Women, 163 Studley Rd, Heidelberg, VIC 3084
Country 138392 0
Australia
Phone 138392 0
+61 417427424
Fax 138392 0
Email 138392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.