Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000593730
Ethics application status
Approved
Date submitted
29/03/2022
Date registered
21/04/2022
Date last updated
21/04/2022
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Usefulness of Augmented Reality Assistance for Percutaneous Nephrolithotomy Access: A Scoping Study
Scientific title
The Usefulness of Augmented Reality Assistance for Percutaneous Nephrolithotomy Access: A Scoping Study
Secondary ID [1] 306791 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urolithiasis 325846 0
Renal Stones 325847 0
Condition category
Condition code
Renal and Urogenital 323166 323166 0 0
Other renal and urogenital disorders
Public Health 323223 323223 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to develop and implement a method of displaying live internal anatomical data on head-mounted display (Microsoft HoloLens system) using augmented reality technology and to use this data to successfully achieve renal access during a Percutaneous Nephrolithotomy.

Pre-oeprative CT images of the patient's urinary system will be used to construct the 3D model which will be projected onto the HoloLens system. The HoloLens system will only be worn at time of initial entry into the patient's renal calyx during percutaneous nephrolithotomy (PCNL).

The procedure will be carried out by Dr Devang Desai, MBBS, FRACS (Urology), Consultant Urologist, at Toowoomba Base Hospital. The procedure will not deviate from a standard PCNL except for the use of the HoloLens system in place of standard image intensifier fluroscopy that is used to typically gain entry into the renal calyx. Standard fluroscopy will be available for use if required. Data concerning success recorded at time of procedure via operator survey. The project aims to be a proof-of-concept that this approach is feasible, while offering initial data on potential expectations of outcome in future studies.
Intervention code [1] 323247 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330914 0
The primary outcome is the ability of augmented reality to guide PCNL puncture. This is measured as a binary positive or negative success in achieving renal access while utilising the technology. This data will be collected directly at time of surgery from the operative note.
Timepoint [1] 330914 0
At time of surgery.
Secondary outcome [1] 408063 0
Number of puncture attempts required to achieve renal access, expressed as a positive integer. This will be collected directly from the procedure note.
Timepoint [1] 408063 0
At time of surgery.
Secondary outcome [2] 408314 0
Qualitative ease of operation
Timepoint [2] 408314 0
Post-operative survey (to be completed immediately post operation by the attending surgeon). This survey will be developed by the research team specifically for this study.
Secondary outcome [3] 408315 0
Speed of access, measured in seconds. This will be measured directly at the time of surgery by the research team.
Timepoint [3] 408315 0
To be measured at time of surgery.

Eligibility
Key inclusion criteria
Urology outpatients clinically determined to require elective Percutaneous Nephrolithotomy as management for Nephrolithiasis, under Dr. Devang Desai.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients planned for intervention other than standard Percutaneous Nephrolithotomy
Non-consenting to trial

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37183 0
4350 - Toowoomba City

Funding & Sponsors
Funding source category [1] 311128 0
University
Name [1] 311128 0
The University of Queensland Rural Clinical School
Country [1] 311128 0
Australia
Primary sponsor type
Hospital
Name
Toowoomba Base Hospital
Address
Pechey St, Toowoomba City QLD 4350
Country
Australia
Secondary sponsor category [1] 312469 0
None
Name [1] 312469 0
Address [1] 312469 0
Country [1] 312469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310657 0
Darling Down Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 310657 0
Corner Hogg and Tor Streets, PO Box 405, Toowoomba, QLD, 4350
Ethics committee country [1] 310657 0
Australia
Date submitted for ethics approval [1] 310657 0
Approval date [1] 310657 0
08/03/2022
Ethics approval number [1] 310657 0
HREC/2022/QTDD/75030/AM01

Summary
Brief summary
We aim to develop and implement a method of displaying live internal anatomical data on head-mounted display using augmented reality technology and use this data to successfully achieve renal access during Percutaneous Nephrolithotomy. Outcomes of interest are:
1. Ability to gain entry to the patient's renal calyx.
2. Number of puncture attempts
3. Ease of access
4. Time taken to achieve entry.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118418 0
Dr Aiyapa Ajjikuttira
Address 118418 0
Darling Downs Hospital and Health Service, Pechey St, Toowoomba City QLD 4350
Country 118418 0
Australia
Phone 118418 0
+610746166000
Fax 118418 0
Email 118418 0
aiyapa.ajjikuttira@health.qld.gov.au
Contact person for public queries
Name 118419 0
Dr Aiyapa Ajjikuttira
Address 118419 0
Darling Downs Hospital and Health Service, Pechey St, Toowoomba City QLD 4350
Country 118419 0
Australia
Phone 118419 0
+610746166000
Fax 118419 0
Email 118419 0
aiyapa.ajjikuttira@health.qld.gov.au
Contact person for scientific queries
Name 118420 0
Dr Aiyapa Ajjikuttira
Address 118420 0
Darling Downs Hospital and Health Service, Pechey St, Toowoomba City QLD 4350
Country 118420 0
Australia
Phone 118420 0
+610746166000
Fax 118420 0
Email 118420 0
aiyapa.ajjikuttira@health.qld.gov.au

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
SourceTitleYear of PublicationDOI
Dimensions AIIntraoperative augmented reality assistance for percutaneous nephrolithotomy—what evidence is emerging?2022https://doi.org/10.21037/amj-22-49
N.B. These documents automatically identified may not have been verified by the study sponsor.