NCT07362524

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

September 27, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

January 23, 2026

Status Verified

October 1, 2025

Enrollment Period

9 months

First QC Date

September 27, 2025

Last Update Submit

January 15, 2026

Conditions

Colorectal Polyps

Outcome Measures

Primary Outcomes (2)

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

    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.

    14 days

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

    14 days

Secondary Outcomes (8)

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

    14 days

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

    14 days

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

    14 days

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

    30 days

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

    14 days

  • +3 more secondary outcomes

Study Arms (2)

CADx assisted colonoscopy group

EXPERIMENTAL
Device: AI-Assisted Real-time Endoscopic Diagnosis System

Routine colonoscopy group

NO INTERVENTION

Endoscopists perform standard endoscopic diagnosis using conventional NBI-based NICE classification without AI assistance.

Interventions

AI-Assisted Real-time Endoscopic Diagnosis SystemDEVICE

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

CADx assisted colonoscopy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nantong First People's Hospital

Nantong, Jiangsu, 200127, China

Location

Wuxi Ninth People's Hospital

Wuxi, Jiangsu, China

Location

Central Study Contacts

Xiaobo Li, PhD

CONTACT

86+13901631056lxb_1969@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 27, 2025

First Posted

January 23, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

January 23, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Locations

CN(2)