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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Colorectal Neoplasms; Adenoma; Colorectal Cancer

Treatments: Device: ENDOCUFF

Study type: Interventional

Funder types: Other

Identifiers

NCT05414448

CREC2022.152

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,726 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,726 participants in 2 patient groups

ENDOAID

No Intervention group

Description:

CADe system will be used during withdrawal phase of colonoscopy.

ENDOAID with ENDOCUFF

Experimental group

Description:

CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy.

Treatment:

Device: ENDOCUFF