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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000314426
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
A prospective, double-blinded, randomised study comparing 16g automated full-core and side-notch biopsy needles for percutaneous renal biopsies in renal transplant patients.
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Scientific title
A prospective, double-blinded, randomised study comparing the quality of samples and safety of 16g automated full-core and side-notch biopsy needles for percutaneous renal biopsies in renal transplant patients
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Secondary ID [1]
314054
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Transplant
336801
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Condition category
Condition code
Renal and Urogenital
333294
333294
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Protocol biopsies of post-transplant kidneys are a safe and important tool in the detection and management of subclinical rejection which is a relatively common and treatable cause of transplant failure. The standard of care, ‘surveillance’, protocol biopsies are performed at 3 and 12 months post-transplant. This minimally invasive procedure is done under ultrasound guidance to ensure precision and safety by a qualified radiologist. Renal transplant patients referred to the Radiology Department for standard of care renal biopsies will be recruited into the study. Standard of care biopsy procedure and follow-up of patients will be conducted during the trial. The patient will be randomised to which needle will be used in the procedure, automated 16g full core or side-notch needles.
Side-notch biopsy needle is a spring-loaded, automatic biopsy system. It features a two-stage release mechanism: the first stage advances the stylet to position the sample notch within the target tissue, and the second stage fires the cutting cannula over the stylet to capture the tissue sample.
Full-core biopsy needles is also a spring-loaded, automatic biopsy system, designed to cut a full core of tissue, providing large specimens for pathological examination. The system operates using a single pincer mechanism that extends from the cannula to cut and separate the tissue sample.
The two needle types have a similar safety profile and approved for use at The Alfred Hospital, the location of the study. All clinicians performing renal biopsy are knowledgeable, trained and competent to use both needles for renal biopsies. Typically, two to three core tissue samples are collected to ensure an adequate specimen for histological examination. Histology staff will be on procedure site to ascertain the quality of sample.
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Intervention code [1]
330702
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Diagnosis / Prognosis
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Comparator / control treatment
16g automated full-core.
Full-core biopsy needles is also a spring-loaded, automatic biopsy system, designed to cut a full core of tissue, providing large specimens for pathological examination. The system operates using a single pincer mechanism that extends from the cannula to cut and separate the tissue sample.
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Control group
Active
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Outcomes
Primary outcome [1]
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Biopsy sample yield
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Assessment method [1]
340870
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The number of passes during will be assessed during the renal biopsy procedure and will be document in the procedure report. The sample percentage of cortex, number of glomeruli, and number of arteries are collectively assessed as a composite primary outcome to evaluate biopsy sample yield in renal biopsy procedures and will be recorded in the histology report.
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Timepoint [1]
340870
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Number of pass will be noted during renal biopsy procedure, all other components assessed via histology report provided within 7 days post biopsy.
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Secondary outcome [1]
445305
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Safety
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Assessment method [1]
445305
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Adverse events and complication rate will be assed as a composite secondary outcome to evaluate the safety of biopsy needles used in the study. Procedure related serious adverse events will be reported to The Alfred Ethics Committee within 72 hours of the event or of knowledge of the event. Significant safety issues (SSI) are not anticipated as the safety profile of both needles is well established and both have TGA approval; SSIs will be reported to The Alfred Hospital Ethics Committee within 72 hours. The researchers will be responsible for assessing adverse events, patient care and determining if the study can be continued.
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Timepoint [1]
445305
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During renal biopsy procedure, immediately after procedure, 24 hours post procedure
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Eligibility
Key inclusion criteria
Adult renal transplant patients referred for renal biopsy
Normal or corrected coagulation profile
Normal or corrected platelet count
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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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Can healthy volunteers participate?
No
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Key exclusion criteria
Age < 18,
Native renal biopsy
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled 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
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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
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
5/04/2022
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Date of last participant enrolment
Anticipated
31/12/2025
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Actual
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Date of last data collection
Anticipated
31/01/2026
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Actual
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Sample size
Target
180
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Accrual to date
70
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
318560
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Hospital
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Name [1]
318560
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Alfred Health
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Address [1]
318560
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Country [1]
318560
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
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Country
Australia
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Secondary sponsor category [1]
320960
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Other Collaborative groups
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Name [1]
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Radiology Research Unit, The Alfred
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Address [1]
320960
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Country [1]
320960
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317160
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
317160
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
317160
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Australia
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Date submitted for ethics approval [1]
317160
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16/12/2021
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Approval date [1]
317160
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05/04/2022
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Ethics approval number [1]
317160
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Summary
Brief summary
To assess and improve our renal biopsy service, we aim to conduct a randomised study comparing automated 16g full core and side-notch needles for adult transplant renal biopsies. The two needle types have a similar safety profile however the difference in the yield and diagnostic value has not been previously assessed. Renal transplant patients referred to the Radiology Department for standard of care renal biopsies will be recruited into the study. Standard of care biopsy procedure and follow-up of patients will be conducted during the trial. Data will be prospectively collected, de-identified and analysed. The findings will be presented at Alfred multidisciplinary meetings, local and/or international conferences and published in the medical peer reviewed literature.
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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 Bruno Di Muzio
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Address
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The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
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Country
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Australia
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Phone
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+61 03 9076 2126
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Fax
140206
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Email
140206
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[email protected]
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Contact person for public queries
Name
140207
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Bruno Di Muzio
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Address
140207
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The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
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Country
140207
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Australia
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Phone
140207
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+61 03 9076 2126
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Fax
140207
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Email
140207
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[email protected]
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Contact person for scientific queries
Name
140208
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Bruno Di Muzion
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Address
140208
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The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
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Country
140208
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Australia
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Phone
140208
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+61 03 9076 2126
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Fax
140208
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Email
140208
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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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