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

Last updated: May 16, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Colon Cancer; Rectal Cancer

Treatment

ENDOCUFF

Clinical Study ID

NCT05414448
CREC2022.152
  • Ages 45-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 45-85 years old;

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

  3. Written informed consent obtained.

Exclusion

Exclusion Criteria:

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

  2. Contraindication or conditions precluding polyp resection (e.g. activegastrointestinal 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 Design

Total Participants: 1726
Treatment Group(s): 1
Primary Treatment: ENDOCUFF
Phase:
Study Start date:
March 07, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Prince of Wales Hospital

    Shatin, Hong Kong Island
    Hong Kong

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.