Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07362524

AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantong First People's Hospital, Nantong, Jiangsu, China

Loading trial locations.

About this study

This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Agree to participate in this prospective randomized controlled study;
  • Age ≥18 years for colonoscopy;
  • At least one colorectal diminutive polyp (size <=5mm) found during examination;

Exclusion criteria

  • Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;
  • Already participating in drug clinical trials and being in the washout period of experimental or control drugs;
  • History of drug or alcohol abuse or psychological disorders in the past five years;
  • Pregnant or lactating patients;
  • Known polyposis syndromes;
  • Patients with gastrointestinal bleeding;
  • Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
  • Patients with contraindications to tissue biopsy;
  • Previous history of allergic reactions to bowel cleansing agent components;
  • Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;
  • Patient's bowel preparation BBPS score <6 for this colonoscopy;
  • Researchers consider the patient unsuitable for trial participation.

Treatment and study plan

AI-Assisted Real-time Endoscopic Diagnosis System

Device

CADx assists endoscopists in diagnosing colorectal diminutive polyps (<=5cm) during colonoscopy using narrow-band imaging (NBI). The system provides real-time prediction values of NICE classification for colorectal polyp. The intervention group receives AI-assisted diagnostic information displayed

Primary outcomes

  1. Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines

    Time frame: 14 days

    The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the U.S. 2020 USMSTF consensus for post-polypectomy surveillance.

  2. Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence

    Time frame: 14 days

Secondary outcomes

  1. Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines

    Time frame: 14 days

    The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the European ESGE 2020 consensus for post-polypectomy surveillance.

  2. Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines

    Time frame: 14 days

    The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Asia-Pacific APWG 2022 consensus for post-polypectomy surveillance.

  3. Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps

    Time frame: 14 days

    The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Expert Consensus on Outpatient Management of Colorectal Polyps (2025, Chengdu).

  4. Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence

    Time frame: 30 days

  5. Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence

    Time frame: 14 days

  6. Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence.

    Time frame: 14 days

  7. Improvement in Endoscopists' Diagnostic Confidence with AI Assistance

    Time frame: 14 days

  8. Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance.

    Time frame: 14 days

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaobo Li, PhD

CONTACT

[email protected]

86+13901631056

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.