NCT07150130

Brief Summary

To address the limitations of current AI-based systems that rely on the assumption of a "constant withdrawal speed," this study proposes the integration of the UPD-3 endoscopic positioning system. By using colonoscope withdrawal videos in combination with UPD-3 imaging data as training samples, we aim to develop an AI-powered bowel cleanliness assessment system that incorporates "withdrawal distance" as a weighting factor. This approach is expected to yield a more reliable, objective, and clinically applicable intelligent assessment system that better aligns with real-world clinical practice and endoscopists' operational habits.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Oct 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Progress20%
Oct 2025Oct 2028

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

Adenoma detection rateBowel preparation assessmentArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Prediction accuracy of the models

    Immediately after models development

Study Arms (4)

Cohort for Module 1

Development and Validation of Module for Exclusion of Unqualified Frames in Colonoscopy Videos

Other: No Intervention: Observational Cohort

Cohort for Module 2

Development and Validation of Module for BBPS 0-3 Scoring for Qualified Colonoscopy Images

Other: No Intervention: Observational Cohort

Cohort for Module 3

Development and Validation of Module for Prediction of Hepatic and Splenic Flexure Locations

Other: No Intervention: Observational Cohort

Cohort for Module 4

Development and Validation of Module for Real-Time Prediction of Withdrawal Distance

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort

Cohort for Module 1Cohort for Module 2Cohort for Module 3Cohort for Module 4

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Colonoscopy images, colonoscopy videos, and colonoscopy videos with the UPD-3 positioning system from the electronic database of our hospital

You may qualify if:

  • Clear colonoscopy images suitable for BBPS scoring
  • Complete and clear colonoscopy videos suitable for BBPS scoring
  • Clear colonoscopy videos with a stable UPD-3 positioning system, without signal drift, disappearance, or other disruptions

You may not qualify if:

  • Blurred colonoscopy images
  • Colonoscopy images taken from the small intestine or outside the patient's body
  • Colonoscopy images captured during irrigation or instrument manipulation
  • Colonoscopy images obtained during chromoendoscopy
  • Colonoscopy videos that do not contain the complete withdrawal process
  • Videos in which the UPD-3 colonoscopic positioning system exhibited signal drift, disappearance, or other instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huadong hospital, Fudan university

Shanghai, 200040, China

Location

Study Officials

  • Danian Ji, M.D.

    Huadong Hospital

    STUDY DIRECTOR

Central Study Contacts

Danian Ji, M.D.

CONTACT

Zhiyu Dong, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations