Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001186549p
Ethics application status
Not yet submitted
Date submitted
1/09/2024
Date registered
27/09/2024
Date last updated
27/09/2024
Date data sharing statement initially provided
27/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
TXI (Texture and Colour Enhancement Imaging) for Detection of Colorectal Lesions in Adults undergoing Colonoscopy
Scientific title
TXI (Texture and Colour Enhancement Imaging) for Detection of Colorectal Lesions in Adults undergoing Colonoscopy
Secondary ID [1] 312859 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polyp 334996 0
Condition category
Condition code
Oral and Gastrointestinal 331510 331510 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
TXI is just an imaging technique which is already built in the software that is used for colonoscopy. The TXI is used simply by toggling a button on the colonoscope which toggles between white light and TXI light.
The duration will be same as duration of the colonoscopy which is about 20 minutes.
The colonoscopy will be performed in the endoscopy suite as standard
There will not be a cross over
intervention will be delivered by gastroenterologists
duration would be duration of procedure, minimum withdrawal time in a colonoscopy is 6 minutes, so at least 6 minutes of using white light or TXI light
Intervention code [1] 329400 0
Early detection / Screening
Comparator / control treatment
The control arm will be participants having colonoscopy with white light.
Control group
Active

Outcomes
Primary outcome [1] 339255 0
detection rate of colorectal lesions , it is a composite outcome
so composite rate of detection of colorectal lesions
Timepoint [1] 339255 0
The specific time to assess the outcome would be at the end of the procedure using either the white light or TXI
Secondary outcome [1] 439285 0
Acceptability of TXI
Timepoint [1] 439285 0
12 months post intervention

Eligibility
Key inclusion criteria
Inclusion Criteria
- Aged 18 years or older undergoing colonoscopy.
- Ability to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
- Inflammatory bowel disease
- Known polyposis syndrome.
- Unable to give informed consent.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317305 0
Hospital
Name [1] 317305 0
Gold Coast University Hospital
Country [1] 317305 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
Country
Australia
Secondary sponsor category [1] 319586 0
None
Name [1] 319586 0
Address [1] 319586 0
Country [1] 319586 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316035 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 316035 0
Ethics committee country [1] 316035 0
Australia
Date submitted for ethics approval [1] 316035 0
01/10/2024
Approval date [1] 316035 0
Ethics approval number [1] 316035 0

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

Contacts
Principal investigator
Name 136578 0
Dr Arif Rehman
Address 136578 0
Royal Brisbane and Women Hospital, Butterfield St, Herston QLD 4006
Country 136578 0
Australia
Phone 136578 0
+61 435742461
Fax 136578 0
Email 136578 0
[email protected]
Contact person for public queries
Name 136579 0
Arif Rehman
Address 136579 0
Royal Brisbane and Women Hospital, Butterfield St, Herston QLD 4006
Country 136579 0
Australia
Phone 136579 0
+61 435742461
Fax 136579 0
Email 136579 0
[email protected]
Contact person for scientific queries
Name 136580 0
Arif Rehman
Address 136580 0
Royal Brisbane and Women Hospital, Butterfield St, Herston QLD 4006
Country 136580 0
Australia
Phone 136580 0
+61 435742461
Fax 136580 0
Email 136580 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24151Study protocol    388380-(Uploaded-01-09-2024-13-59-13)-TXI protocol.doc



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.