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Active Not Recruiting NCT07453056

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

Conditions: AI App Improves Bowel Preparation Quality for Colonoscopy

Sex: All
Ages: 20 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 340
Sponsor: Fu Jen Catholic University Hospital

Location: Fu Jen Catholic University Hospital New Taipei City Taishan District

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 Criteria

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07453056). StuddyBuddy aggregates publicly available trial information.