Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training (ENDOAIDTRAIN)
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ClinicalTrials.gov Identifier: NCT04838951 |
Recruitment Status :
Completed
First Posted : April 9, 2021
Last Update Posted : February 8, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | March 23, 2021 | ||||
First Posted Date ICMJE | April 9, 2021 | ||||
Last Update Posted Date | February 8, 2023 | ||||
Actual Study Start Date ICMJE | April 19, 2021 | ||||
Actual Primary Completion Date | July 22, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
ADR [ Time Frame: During the colonoscopy ] adenoma detection rate
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training | ||||
Official Title ICMJE | Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study | ||||
Brief Summary | The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists. | ||||
Detailed Description | Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes. As a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise. Recently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm. Nevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown. In this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Masking Description: Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts. Primary Purpose: Treatment
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Condition ICMJE | Screening Colonoscopy | ||||
Intervention ICMJE | Device: ENDO-AID CADe
ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
856 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | December 31, 2022 | ||||
Actual Primary Completion Date | July 22, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Hong Kong | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04838951 | ||||
Other Study ID Numbers ICMJE | 2021.141 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Louis Ho Shing Lau, Chinese University of Hong Kong | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chinese University of Hong Kong | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |