The Auxiliary Effect of Artificial Intelligence in the De... | NCT07338643

Studies
The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

NCT07338643

Sponsor

Limian Er

Status

Not yet recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Abdominal Pain
Black Stools
Constipation
Diarrhea

Interventions

AI group
Serial group
Standard colonoscopy group

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2026Estimated

Primary Completion Date

Aug 1, 2028Estimated

Completion Date

Aug 1, 2028Estimated

First Submitted Date

Dec 18, 2025

First Submission Date that Met QC Criteria

Jan 3, 2026

First Posted Date

Jan 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2026

Last Update Posted Date

Jan 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Limian Er, The director of the Endoscopy Department of the Fourth Hospital of Hebei Medical University, Hebei Medical University Fourth HospitalSponsor-Investigator

Lead Sponsor

Limian ErOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI group			Procedure: AI group
Series group			Procedure: Serial group
Standard group			Procedure: Standard colonoscopy group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AI group	Procedure	Full AI assistance was used throughout the standard colonoscopy procedure.	AI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	The proportion of patients who have at least one adenoma detected during colonoscopy examination	Day 1
Average adenoma detection rate	The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.

Exclusion Criteria:

Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
Those with intestinal obstruction or malignant tumors
Patients with colorectal lesions that need to be treated in stages.
Other contraindications for colonoscopy examination.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li mian Er, doctor	Contact	13513379068		Hbsyelm@163.com
Zhenzhen Wang, master	Contact	13803365602		13803365602@163.com

Overall Officials

Name	Affiliation	Role
Li mian Er	Hebei Medical University Fourth Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Fourth Hospital of Hebei Medical University		Shijiazhuang	Hebei	050000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32968933	Background	Luo Y, Zhang Y, Liu M, Lai Y, Liu P, Wang Z, Xing T, Huang Y, Li Y, Li A, Wang Y, Luo X, Liu S, Han Z. Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study. J Gastrointest Surg. 2021 Aug;25(8):2011-2018. doi: 10.1007/s11605-020-04802-4. Epub 2020 Sep 23.
39688959	Background

ID	Term
D015746	Abdominal Pain
D008551	Melena
D003248	Constipation
D003967	Diarrhea

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms