Skip to main content
OpenTrials
Completed

NCT Number: NCT05414448

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong Island, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

endocuff

Device

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

Primary outcomes

  1. ADR

    Time frame: During the colonoscopy

    adenoma detection rate

Secondary outcomes

  1. ADR for adenomas of different sizes

    Time frame: During the colonoscopy

    <5mm, 5-10mm, >10mm

  2. ADR for adenomas of different colonic segments

    Time frame: During the colonoscopy

    caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum

  3. Mean number of adenomas per colonoscopy

    Time frame: During the colonoscopy

    Mean number of adenomas per colonoscopy

  4. Advanced adenoma detection rate

    Time frame: During the colonoscopy

    Advanced adenoma detection rate

  5. Sessile serrated lesion (SSL) detection rate

    Time frame: During the colonoscopy

    Sessile serrated lesion (SSL) detection rate

  6. Polyp detection rate

    Time frame: During the colonoscopy

    Polyp detection rate

  7. Non-neoplastic resection rate

    Time frame: During the colonoscopy

    defined as absence of adenoma or SSL or cancer within resected specimen

  8. Caecal intubation time

    Time frame: During the colonoscopy

    Caecal intubation time

  9. Withdrawal time

    Time frame: During the colonoscopy

    excluding interventions

  10. Total procedural time

    Time frame: During the colonoscopy

    Total procedural time

  11. False positive rate

    Time frame: During the colonoscopy

    defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Changi General Hospital
  • University Hospital Augsburg

Registry information

Official study title

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

Acronym: AIDEN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2022
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.