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

NCT05414448 | Completed DMC

• 1 other identifier: CREC2022.152
• Study Type: interventional
• Target: 1,726
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoma; Colorectal Cancer; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• ADR

  adenoma detection rate

  During the colonoscopy

Secondary Outcomes (11)

• ADR for adenomas of different sizes

  During the colonoscopy

• ADR for adenomas of different colonic segments

  During the colonoscopy

• Mean number of adenomas per colonoscopy

  During the colonoscopy

• Advanced adenoma detection rate

  During the colonoscopy

• Sessile serrated lesion (SSL) detection rate

  During the colonoscopy

Study Arms (2)

ENDOAID

NO INTERVENTION

CADe system will be used during withdrawal phase of colonoscopy.

ENDOAID with ENDOCUFF

EXPERIMENTAL

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

Device: ENDOCUFF

Interventions

ENDOCUFF DEVICE

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

ENDOAID with ENDOCUFF

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45-85 years old;
• They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;
• Written informed consent obtained.

You may not qualify if:

• Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
• Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
• Staged procedure for polypectomy or biopsy of known unresected lesions
• Previous surgical resection of colon
• Personal history of colorectal cancer
• Personal history of familial polyposis syndrome
• Personal history of inflammatory bowel disease
• Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
• Pregnancy
• Unable to obtain informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University Hospital Augsburg: collaborator
• Changi General Hospital: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong Island, Hong Kong

Location

MeSH Terms

Conditions

Adenoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: March 7, 2023
• Primary Completion: July 7, 2025
• Study Completion: December 31, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)