Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection

Colorectal Cancer Clinical Trial

— AIDEN  

Official title:

Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414448
• Other study ID #: CREC2022.152
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: Felix Sia
• Phone: 26370428
• Email: felixsia[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.

Description:

High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.

To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.

Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.

In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1726
• Est. completion date: December 31, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Aged 45-85 years old;

2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;

3. Written informed consent obtained.

Exclusion Criteria:

1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)

2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)

3. Staged procedure for polypectomy or biopsy of known unresected lesions

4. Previous surgical resection of colon

5. Personal history of colorectal cancer

6. Personal history of familial polyposis syndrome

7. Personal history of inflammatory bowel disease

8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)

9. Pregnancy

10. Unable to obtain informed consent

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• ENDOCUFF
ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	Hong Kong Island

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Changi General Hospital, University Hospital Augsburg

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADR	adenoma detection rate	During the colonoscopy
Secondary	ADR for adenomas of different sizes	<5mm, 5-10mm, >10mm	During the colonoscopy
Secondary	ADR for adenomas of different colonic segments	caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum	During the colonoscopy
Secondary	Mean number of adenomas per colonoscopy	Mean number of adenomas per colonoscopy	During the colonoscopy
Secondary	Advanced adenoma detection rate	Advanced adenoma detection rate	During the colonoscopy
Secondary	Sessile serrated lesion (SSL) detection rate	Sessile serrated lesion (SSL) detection rate	During the colonoscopy
Secondary	Polyp detection rate	Polyp detection rate	During the colonoscopy
Secondary	Non-neoplastic resection rate	defined as absence of adenoma or SSL or cancer within resected specimen	During the colonoscopy
Secondary	Caecal intubation time	Caecal intubation time	During the colonoscopy
Secondary	Withdrawal time	excluding interventions	During the colonoscopy
Secondary	Total procedural time	Total procedural time	During the colonoscopy
Secondary	False positive rate	defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds	During the colonoscopy