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A single-group, single-center study on the effectiveness and safety of artificial intelligence-assisted system in polyp detection and polyp classification

A single-group, single-center study on the effectiveness and safety of artificial intelligence-assisted system in polyp detection and polyp classification

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046441
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-05-16
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal polyps

Interventions

Gold Standard:Pathological diagnosis
Index test:Artificial&#32
intelligence&#32
colonoscopy

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged over 18 years (inclusive), no gender limit; 2. Colorectoscope and related examinations are needed to further clarify the characteristics of digestive tract diseases; 3. Able to read, understand and sign the informed consent form; 4. The researcher believes that the subject can understand the process of the clinical research, willing and able to complete all research procedures and follow-up visits, and cooperate with the research procedures.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical trials, signed the informed consent form and within the follow-up period of other clinical trials; 2. Existence of drug or alcohol abuse or psychological disorder in the last 5 years; 3. Women during pregnancy or breastfeeding; 4. Subjects with a history of colorectal surgery; 5. The researcher believes that the subject is not suitable for high-risk diseases or other special circumstances to participate in clinical trials. 6. Known multiple polyp syndrome; 7. Patients with inflammatory bowel disease; 8. Patients with colorectal cancer; 9. Patients with contraindications to biopsy.

Design outcomes

Primary

MeasureTime frame
Accuracy of polyp classification;

Secondary

MeasureTime frame
Sensitivity, specific and negative predictive value of polyp classification;

Countries

China

Contacts

Public ContactYu Honggang

Renmin Hospital of Wuhan University

yuhonggang@whu.edu.cn+86 13871281899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026