Development and Demonstration of a Precision Prevention and Treatment System for Colorectal Tubular Adenomas Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRenmin Hospital of Wuhan University

About this trial

This study is a prospective,multi-center and observational clinical study.Investigators would like to innovatively construct a "trinity" database of colorectal tubular adenomas based on white light - magnifying chromo - pathological images.It simulates the decision - making logic of doctors, and based on the multimodal endoscopic LAFEQ method previously proposed, develop a multimodal deep - learning diagnostic model for colon adenomas and an interpretable risk prediction model for intestinal adenomas. While achieving high - precision auxiliary treatment decisions, clearly present the decision - making basis, and break through the limitation of poor interpretability of previous medical imaging AI models.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 18 years, who need to undergo colonoscopy, regardless of gender.

Voluntarily sign the informed consent form

Promise to abide by the research procedures and cooperate in the implementation of the entire research process.

Disqualifiers

Patients who has a history of abdominal or pelvic surgery or radiotherapy in the past;

Patients who has definite active lower gastrointestinal bleeding.

Existing or suspected hereditary colorectal polyposis, inflammatory bowel disease;

Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg after standardized treatment)

Trial population

Patients withonic col adenomas or polyps

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • AI models with NBI

    Device

    AI models for detecting intestinal adenoma in magnifying endoscopy with NBI.

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: Traditional colonoscopy examination group0 interventions
Group B: AI-assisted colonoscopy examination group1 intervention

Trial outcomes

Primary outcomes

1

The accuracy rate of diagnosing adenomas

The prediction rate of the interpretable artificial intelligence-assisted diagnosis model for the disease risk level.

Time frame
during endoscopy

Secondary outcomes

1

The prediction for the disease risk level

The prediction rate of the interpretable artificial intelligence-assisted diagnosis model for the disease risk level.

Time frame
during endoscopy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Renmin Hospital of Wuhan University

Lead sponsor

Wuhan University

Sponsor institution

Beijing Friendship Hospital, Captial Medical University

Collaborator

Air Force Military Medical University, China

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

Army Medical University, China

Collaborator

Guizhou Provincial People's Hospital

Collaborator

Shengjing Hospital

Collaborator

The Second Medical Center, Chinese PLA General Hospital

Collaborator

Zhejiang University

Collaborator

Shandong University

Collaborator