NCT04901130

Brief Summary

The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

May 24, 2021

Last Update Submit

May 24, 2021

Conditions

Colonoscopy

Keywords

Artificial IntelligenceColonoscopyQuality Control

Outcome Measures

Primary Outcomes (1)

  • Colorectal adenoma detection rate (ADR)

    The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.

    10 months

Secondary Outcomes (4)

  • Colorectal polyp detection rate (PDR)

    10 months

  • The mean number of adenomas detected per colonoscopy (APC)

    10 months

  • The mean number of polyps detected per colonoscopy (PPC)

    10months

  • Withdrawl time

    During procedure

Study Arms (2)

AQCS-aided group

EXPERIMENTAL

Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.

Device: Computer-aided Real-time Automatic Quality Control System (AQCS)

Control group

NO INTERVENTION

Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS.

Interventions

Computer-aided Real-time Automatic Quality Control System (AQCS)DEVICE

Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection.

AQCS-aided group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.

You may not qualify if:

  • Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
  • Patients with a history of colorectal surgery.
  • Patients with a contraindication for biopsy.
  • Patients with prior failed colonoscopy.
  • Patients with known stenosis or obstruction.
  • Patients in pregnancy or lactation phase.
  • Patients refused to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Binzhou Medical University Hospital

Binzhou, Shandong, China

Location

Linyi People's Hospital

Dezhou, Shandong, China

Location

Central Hospital of Shengli Oilfield

Dongying, Shandong, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

The People's Hospital of Zhaoyuan City

Yantai, Shandong, China

Location

Zibo Municipal Hospital

Zibo, Shandong, China

Location

Related Publications (1)

  • Liu J, Zhou R, Liu C, Liu H, Cui Z, Guo Z, Zhao W, Zhong X, Zhang X, Li J, Wang S, Xing L, Zhao Y, Ma R, Ni J, Li Z, Li Y, Zuo X. Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2457241. doi: 10.1001/jamanetworkopen.2024.57241.

    PMID: 39883463DERIVED

Study Officials

  • Yanqing Li, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

  • Xiuli Zuo, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Zhen Li, PhD

CONTACT

18560086106lizhenh@hotmail.com

Jing Liu, MD

CONTACT

18366118559liujingqdpd@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 25, 2021

Study Start

May 27, 2021

Primary Completion

January 1, 2022

Study Completion

January 31, 2022

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations

CN(6)