Status:

COMPLETED

Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

Lead Sponsor:

Evergreen General Hospital, Taiwan

Collaborating Sponsors:

Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy

The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA

Conditions:

Colon Adenoma

Colonoscopy

Eligibility:

All Genders

45-75 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to compare the detected adenoma per colonoscopy (APC) in participants undergoing screening, surveillance, and positive fecal immunochemical test (FIT) or guaiac feca...

Detailed Description

This will be a multi-site, multi-national, unblinded investigators, prospective Random Control Trial (RCT). Randomization (1:1 to WE alone and WE-AI) will be based on computer generated random numbers...

Eligibility Criteria

Inclusion

  • Male and female patients aged 45-75 years at average risk for colorectal cancer who plan to undergo colonoscopy for primary screening, postpolypectomy surveillance, and individuals with positive fecal immunochemical test or guaiac fecal occult blood test results.

Exclusion

  • Patients with a history of inflammatory bowel disease
  • Patients with hereditary colorectal cancer syndrome or serrated polyposis syndrome
  • Patients with a personal history of colorectal cancer
  • Patients with a history of colorectal resection
  • Patients with colonic stricture
  • Patient with severe comorbid illnesses rendering polypectomy unsafe
  • Patients with colonoscopy contraindications (e.g., acute diverticulitis or toxic megacolon)
  • Therapeutic colonoscopy (e.g., hemostasis, removal of a large polyp)
  • Emergent colonoscopy
  • Pregnant women or those planning pregnancy
  • Patients unwilling to participate in the study

Key Trial Info

Start Date :

December 18 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 5 2025

Estimated Enrollment :

560 Patients enrolled

Trial Details

Trial ID

NCT06173258

Start Date

December 18 2023

End Date

January 5 2025

Last Update

February 14 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

CTO Hospital

Iglesias, Italy, 09016

2

Chi-Liang Cheng

Taoyuan District, Taiwan, 320

Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection | DecenTrialz