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Clinical Trials in Taiwan / NCT07453056
Active, not recruiting Not applicable

The Efficacy of AI-Driven Feces Identification for Bowel Preparation Prior to Colonoscopy

NCT07453056 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Fu Jen Catholic University Hospital
Phase
Not applicable
Started
2025-09-04
Last updated
2026-07-21

Condition(s) studied

AI App Improves Bowel Preparation Quality for Colonoscopy

Investigational drug(s) / intervention(s)

A Prospective, Randomized, Evaluator Blind, Parallel Study of the Efficacy of AI-driven feces identifying for the Bowel Preparation Prior to Colonoscopyeducational leaflet without APP

A Prospective, Randomized, Evaluator Blind, Parallel Study of the Efficacy of AI-driven feces identifying for the Bowel Preparation Prior to Colonoscopy: educational leaflet and APP for reaching AI-SIS for AI aid

educational leaflet without APP: educational leaflet without APP

Study summary

The objective is to enhance diagnostic outcomes by ensuring thorough bowel cleanliness through AI-driven stool identifying system for bowel preparation in subjects undergoing colonoscopy.Colonoscopy is a key procedure for the prevention and early detection of colorectal cancer, with its diagnostic accuracy highly dependent on the quality of bowel preparation. Inadequate bowel cleansing can lead to missed lesions, prolonged procedure times, and the need for repeat examinations. Despite public health efforts that have improved screening rates over the past decade, the adequacy of bowel preparation has remained relatively unchanged, posing a persistent clinical challenge.

With the rapid advancement of artificial intelligence (AI) technologies, deep learning-based image recognition has demonstrated outstanding performance in medical imaging applications. Recent studies have shown that AI can assist in real-time evaluation of stool appearance, providing patients with immediate feedback and personalized instructions to improve bowel preparation quality. Integrating AI systems into bowel cleansing protocols has the potential to enhance patient compliance, optimize bowel cleanliness, and consequently improve the diagnostic yield of colonoscopy.

This study aims to evaluate the efficacy of an AI-based stool identifying system (AI-SIS), combined with the use of a Prepackaged Low Residue Diet (PLD) and standard bowel preparation instructions. Through a prospective, randomized, evaluator-blind, parallel-group clinical trial design, the study seeks to generate scientific evidence supporting the integration of AI technology into routine bowel preparation practices.

Eligibility

Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Men or women 20 and 60 years of age. 2. Subject who are scheduled for colonoscopy. 3. Ability to complete the entire procedure and to comply with study instructions. 4. Will provide completed and signed written informed consents Exclusion Criteria: 1\. Patients who are unsuitable for Bowklean use due to known contraindications, including but not limited to: 1. Allergies or hypersensitivity to Bowklean or its ingredients. 2. Severe gastrointestinal conditions (e.g., obstruction, perforation). 3. Renal impairment or electrolyte imbalances (e.g., severe hyponatremia). 4. Recent gastrointestinal surgery affecting bowel preparation. 2. Cognitive, language, or other barriers that prevent completion of the questionnaire. 3\. Non-compliance with the bowel preparation protocol or inability to follow dietary restrictions (e.g., Prepackaged low residue diet, PLD).

Primary outcome measure(s)

  • Primary Outcome Measure — 45 days
    The percentage of subjects achieving adequate bowel cleansing, represented by a score of each segment ≥2 or higher on the BBPS.

Trial sites (1)

FacilityCityRegionStatus
Fu Jen Catholic University Hospital New Taipei City Taishan District

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07453056 on ClinicalTrials.gov ↗ ← All trials in Taiwan