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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02196649




Registration number
NCT02196649
Ethics application status
Date submitted
17/07/2014
Date registered
22/07/2014
Date last updated
29/06/2023

Titles & IDs
Public title
Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial
Scientific title
Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
Secondary ID [1] 0 0
HREC2014/5/4.2(3971)
Universal Trial Number (UTN)
Trial acronym
CuRB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Endoscopic Clipping - Participants randomised to the arm will receive endoscopic clips to their defect following EMR.

No intervention: No Endoscopic Clipping - These participants will receive standard of care practice only.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-Procedural Bleeding
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Safety success
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
* Can give informed consent to trial participation
* Lesion size greater than 20 mm
* Lesion proximal to and inclusive of mid transverse colon
* Laterally spreading or sessile polyp morphology
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous resection or attempted resection of lesion
* Clip deployed prior to the completion of the EMR
* Major intraprocedural bleeding not treatable by coagulation
* Endoscopic appearance of invasive malignancy
* Age less than 18 years
* Pregnancy
* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
* Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
* American Society of Anesthesiology (ASA) Grade IV-V

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
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
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2021
Sample size
Target
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Michael J Bourke, MBBS
Address 0 0
Western Sydney Local Health District
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

No information has been provided regarding IPD availability


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/NCT02196649