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The evaluation of the effectiveness and safety of artificial intelligence endoscopy image-assisted diagnostic software for colorectal polyps, as well as the classification of colorectal polyps in light of endoscopic electron staining.

The evaluation of the effectiveness and safety of artificial intelligence endoscopy image-assisted diagnostic software for colorectal polyps, as well as the classification of colorectal polyps in light of endoscopic electron staining.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090942
Enrollment
Unknown
Registered
2024-10-16
Start date
2022-09-07
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Colorectal polyps and colorectal cancer

Interventions

Gold Standard:Histopathological examination of suspected lesions was performed during colonoscopy.
Index test:Artificial intelligence endoscopy image-assisted diagnostic software for colorectal polyps was used to identify polyps and distinguish polyp morphological features

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 40 to 75 years (including 40 and 75 years); 2) People who plan to undergo colonoscopy due to screening (colorectal cancer risk score * total score =4) or clinical diagnostic needs; 3) Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1) Polypectomy within the last 5 years; 2) Previous history of abdominal and pelvic surgery; 3) Previous history of abdominal and pelvic radiotherapy and chemotherapy; 4) Definite active intestinal polyp digestive bleeding; 5) Existing or suspected hereditary colorectal polyposis, inflammatory bowel disease or inflammatory bowel disease; 6) Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95mmHg); 7) History of acute stroke, coronary artery disease or vascular disease; 8) Inability to perform intestinal preparation; 9) Other conditions that could not accept digestive endoscopy for intestinal polyps; 10) Participants who have participated in other clinical trials within 1 month; 11) The researcher considers that any other factors are not suitable for inclusion or affect the participant's participation in the study.

Design outcomes

Primary

MeasureTime frame
polyp per colonoscopy,PPC;Sensitivity;

Secondary

MeasureTime frame
adenoma detection rate;adenoma per colonoscopy, APC;polyp detection rate, PDR;Accuracy;Specifity;Positive Predictive Value;Negative Predictive Value;Receiver Operating Characteristic (ROC);Area Under the Curve (AUC);

Countries

China

Contacts

Public ContactWang Bangmao

Anshan Road NO.154, Tianjin Medical University General Hospital

mwang02@tmu.edu.cn+86 136 0200 7150

Outcome results

None listed

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