NCT05941689

Brief Summary

This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,906

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 10, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 4, 2023

Last Update Submit

October 9, 2023

Conditions

Adenoma Colon

Outcome Measures

Primary Outcomes (2)

  • adenoma detection rate

    The proportion of patients with at least one histologically proven adenoma or carcinoma

    up to 2months

  • withdrawal time compliance rate

    The proportion of patients with clean withdrawal time \>6min.

    up to 2months

Secondary Outcomes (3)

  • polyp detection rate

    up to 2 months

  • adenoma per colonoscopy

    up to 2 months

  • polyp per colonoscopy

    up to 2 months

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Subjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control.

Device: AI-assisted colonoscopy

control group

NO INTERVENTION

Subjects in this group undergo routine colonoscopy.

Interventions

AI-assisted colonoscopyDEVICE

AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.

AI-assisted group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

Loudi Central Hospital

Loudi, Hunan, China

Location

Study Officials

  • Xiaowei Liu, doctor

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 12, 2023

Study Start

July 25, 2023

Primary Completion

September 20, 2023

Study Completion

September 30, 2023

Last Updated

October 10, 2023

Record last verified: 2023-07

Locations

CN(2)