Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

Phase

N/A

Condition

Colon Cancer Screening

Treatment

Artificial Intelligence plus Water exchane

Water exchange plus Artificial Intelligence (AI)

Water exchange alone

Clinical Study ID

NCT06173258

WEAID

Ages 45-75
All Genders
Accepts Healthy Volunteers

Study 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 fecal occult blood test (gFOBT). There will be two arms in this study: WE water control and water plus artificial intelligence (AI). The main question it aims to answer is whether the addition of AI into water exchange (WE) colonoscopy increases APC than WE alone. The control method will use water instead of air inserted into the colon. The study method will use a commercially available AI system plus water during the procedure. Researchers will compare APCs to see if the addition of AI increases detection of adenomas during WE colonoscopy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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 toxicmegacolon)
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

Study Design

Artificial Intelligence plus Water exchane

December 18, 2023

January 05, 2025

Study 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 placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different methods with two arms (WE, WE-AI) to see which one is better at detecting adenomas.

Patient recruitment will be conducted at three hospitals in Italy and Taiwan: Digestive Endoscopy Unit, CTO Hospital, Iglesias, Italy; Digestive Endoscopy and Gastroenterology Unit, Manzoni Hospital, Lecco, Italy; Evergreen General Hospital, Taoyuan, Taiwan. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. The study period is expected to be 3 years (from November 2023 to October 2026).

Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (primary screening, surveillance, or positive FIT or gFOBT). Mode of sedation will include unsedated, on demand sedation, conscious sedation or full sedation with propofol. Randomization will be carried out by computer-generated sequences using a block design (four participants per block).

Control Method: One arm of the study will include sedated/unsedated colonoscopy with water (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.

Study method: The other arm entail the addition of a commercially available AI system (CAD-EYE, Fujifilm; Endo-AID, Olympus) to the high-definition colonoscopy system. This arm includes sedated/unsedated colonoscopy with AI detection device plus water (WE).

Connect with a study center

CTO Hospital
Iglesias, 09016
Italy
Site Not Available
Manzoni Hospital
Lecco, 23900
Italy
Site Not Available
Dalin Tzu Chi General Hospital
Chiayi, 622
Taiwan
Site Not Available
Chi-Liang Cheng
Taoyuan, 320
Taiwan
Site Not Available

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.