Status:

RECRUITING

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

Lead Sponsor:

Chinese University of Hong Kong

Collaborating Sponsors:

University Hospital Augsburg

Changi General Hospital

Conditions:

Adenoma

Colorectal Cancer

Eligibility:

All Genders

45-85 years

Phase:

NA

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.

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 miss...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 7 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

1726 Patients enrolled

Trial Details

Trial ID

NCT05414448

Start Date

March 7 2023

End Date

December 31 2025

Last Update

May 17 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Prince of Wales Hospital

Shatin, Hong Kong Island, Hong Kong