Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000996460
Ethics application status
Approved
Date submitted
14/08/2025
Date registered
9/09/2025
Date last updated
9/09/2025
Date data sharing statement initially provided
9/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The addition of computer aided detection to texture and colour enhancement imaging (TXI) for adenoma detection during colonoscopy: have we reached a glass ceiling?
Scientific title
Adenoma detection during colonoscopy: have we reached a glass ceiling? The impact of the addition of computer aided detection to texture and colour enhancement imaging in adult patients undergoing colonoscopy
Secondary ID [1] 315135 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon polyps 338558 0
Condition category
Condition code
Oral and Gastrointestinal 334863 334863 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of texture and colour enhancement imaging (TXI) - a form of advanced endoscopic imaging technology, in combination with artificial intelligence for the detection of colonic polyps. TXI is a 'push-button' technology included with Olympus endoscopy systems which will be set in use for the entire colonoscope withdrawal. Artificial intelligence (computer aided detection) is an additional system that can be added to the Olympus endoscopy system, which uses artificial intelligence to identify and highlight colonic polyps. The anticipated time of colonoscopy is approximately 20 minutes, with AI processing occurring in real time. The procedures will be performed by consultant gastroenterologists in both the intervention and control groups. The computer aided detection images will be incorporated into a single colonoscopy report completed by the gastroenterologist. The intervention will be delivered once at the time of colonoscopy and includes only the index colonoscopy. This will be performed at two tertiary centres in South Australia. Patients are not required to adhere to the intervention. All proceduralists are involved as associate investigators and aware of the trial protocol. The principal investigator will be providing oversight to ensure adherence.
Intervention code [1] 331758 0
Early detection / Screening
Comparator / control treatment
Historical control group - this includes patients from a previous randomised controlled trial conducted under the same conditions, in the same location, with the same inclusion and exclusion criteria (ACTRN12621000708853). The historical control group will consist of the 'TXI' or intervention arm from our previous randomised controlled trial. This data was collected between 2021-2023. The data points included in this study are the same data points that were collected for the historical controls.
Control group
Historical

Outcomes
Primary outcome [1] 342491 0
Adenomas detected per colonoscopy
Timepoint [1] 342491 0
At the time of index colonoscopy
Secondary outcome [1] 451029 0
Adenoma detection rate
Timepoint [1] 451029 0
At index colonoscopy
Secondary outcome [2] 451030 0
Colonoscope withdrawal time
Timepoint [2] 451030 0
At index colonoscopy
Secondary outcome [3] 451031 0
Non-neoplastic polyps resected per colonoscopy
Timepoint [3] 451031 0
At index colonoscopy

Eligibility
Key inclusion criteria
All patients presenting for colonoscopy at the Lyell McEwin Hospital or Modbury Hospital
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coagulation disorders
Significant comorbidity (severe heart failure, chronic kidney disease or chronic obstructive pulmonary disease)
Pregnancy
Personal history of inflammatory bowel disease
Family history of polyposis or non-polyposis bowel cancer syndromes

Study design
Purpose of the study
Diagnosis
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
Other
Other design features
This is a prospective non-randomised trial where the intervention group will be compared to a historical control group (ACTRN12621000708853).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2024
Date of last participant enrolment
Anticipated
Actual
15/05/2025
Date of last data collection
Anticipated
Actual
22/08/2025
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319712 0
Self funded/Unfunded
Name [1] 319712 0
Country [1] 319712 0
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 322220 0
None
Name [1] 322220 0
Address [1] 322220 0
Country [1] 322220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318265 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 318265 0
Ethics committee country [1] 318265 0
Australia
Date submitted for ethics approval [1] 318265 0
07/03/2024
Approval date [1] 318265 0
16/05/2024
Ethics approval number [1] 318265 0
19246

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

Contacts
Principal investigator
Name 143634 0
Dr Edward Young
Address 143634 0
Lyell McEwin Hospital, Department of Gastroenterology. Haydown Road, Elizabeth Vale, SA 5112
Country 143634 0
Australia
Phone 143634 0
+61 8 82821897
Fax 143634 0
Email 143634 0
[email protected]
Contact person for public queries
Name 143635 0
Edward Young
Address 143635 0
Lyell McEwin Hospital, Department of Gastroenterology. Haydown Road, Elizabeth Vale, SA 5112
Country 143635 0
Australia
Phone 143635 0
+61 881829000
Fax 143635 0
Email 143635 0
[email protected]
Contact person for scientific queries
Name 143636 0
Edward Young
Address 143636 0
Lyell McEwin Hospital, Department of Gastroenterology. Haydown Road, Elizabeth Vale, SA 5112
Country 143636 0
Australia
Phone 143636 0
+61 881829000
Fax 143636 0
Email 143636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.