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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02581254




Registration number
NCT02581254
Ethics application status
Date submitted
15/10/2015
Date registered
20/10/2015

Titles & IDs
Public title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps
Scientific title
Thin Wire Versus Thick Wire Snare for Cold Snare Polypectomy of Diminutive Polyps- A Randomised Controlled Trial
Secondary ID [1] 0 0
HREC/15/WMEAD/97 (4237)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polyps 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Thin Wire Snare Arm - Use of Thin Wire Snare to resect polyp \<10mm

Experimental: Thick Wire Snare Arm - Use of Thick Wire Snare to resect polyp \<10mm
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incomplete resection rate of diminutive polyps
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Percentage of protrusions
Timepoint [2] 0 0
1 year
Secondary outcome [1] 0 0
Measurement of the need for second excision in case of endoscopically visual residual adenoma
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Post polypectomy bleeding requiring intervention
Timepoint [2] 0 0
1 year

Eligibility
Key inclusion criteria
* Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
* Patients referred to Auburn Hospital Endoscopy Unit for a colonoscopy for whatever reason
* At least 1 lesion <10mm beyond the rectosigmoid junction without any endoscopic features of malignancy
* At least 1 lesion <10mm beyond the rectosigmoid junction that according to the proceduralist, can be safely removed with CSP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted
* Known coagulopathy
* Pregnancy
* If any doubt about the benign character of the polyp, the patient will be excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
Accrual to date
Final
660
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Auburn Hosptial - Auburn
Recruitment postcode(s) [1] 0 0
2144 - Auburn

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Eric Dr Lee, FRACP
Address 0 0
Westmead Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02581254