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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Adenoma
• Intervention / Treatment: Device: ENDOCUFF

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1726
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong Island
    • Shatin, Hong Kong Island, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ENDOAID; CADe system will be used during withdrawal phase of colonoscopy.
Experimental: ENDOAID with ENDOCUFF; CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy.	Device: ENDOCUFF; ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADR	adenoma detection rate	During the colonoscopy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Changi General Hospital; University Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: CREC2022.152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No