Prospective Evalulation of Artificial Intelligence-assisted Monitoring of Effective Withdrawal Time Versus Standard Withdrawal Time on Adenoma Detected Per Colonoscopy

NCT06345105 | Completed

• 1 other identifier: AIeffectiveV4
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' adenoma per colonoscopy (APC), polyp per colonoscopy(PPC), adenoma detection rate (ADR), polyp detection rate (PDR) and during colonoscopy for each endoscopists. The association between the AI derived EWT with all colonoscopy outcomes during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI. The result will be compared with standard withdrawal time (SWT).

Conditions

Colon Polyp; Colon Adenoma; Artificial Intelligence

Keywords

Colon Polyp; Artificial Intelligence; Withdrawal time

Outcome Measures

Primary Outcomes (1)

• Adenoma per colonoscopy of the endoscopists

  Adenoma per colonoscopy of the endoscopists

  During the colonoscopy

Secondary Outcomes (5)

• Adenoma detection rate of the endoscopists

  During that colonoscopy

• Polyp detection rate of the endoscopists

  During that colonoscopy

• Polyp per colonoscopy of the endoscopists

  During colonoscopy

• Serrated Lesion per Colonoscopy of the endoscopist

  During the colonoscopy

• Serrated Lesion Detection Rate of the endoscopist

  During colonoscopy

Study Arms (1)

AI group

AI monitoring of effective withdrawal time

Device: Endoscreener QC

Interventions

Endoscreener QC DEVICE

Artificial intelligence monitoring of effective withdrawal time

AI group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient will be recruited in Queen Mary Hospital, Hong Kong, China

You may qualify if:

• All adult patients, aged 40 or above, undergoing outpatient colonoscopy will be recruited

You may not qualify if:

• history of inflammatory bowel disease
• history of colorectal cancer
• previous bowel resection (apart from appendectomy)
• Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
• bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
• Cecum could not be intubated for various reasons
• Poor bowel preparation with Boston Bowel Preparation Scale (BBPS) \< 6

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, the University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Ka-Luen Lui

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 3, 2024
• Study Start: November 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: January 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2023-11

Locations

HK (1)