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A clinical trial to validate the effectiveness and safety of AI-assisted colonoscopy

A clinical trial to validate the effectiveness and safety of AI-assisted colonoscopy

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073421
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-07-11
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

polyp, adenoma

Interventions

Gold Standard:The expert review
Index test:AI-assisted colonoscopy

Sponsors

Beijing Friendship Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1)18 years old = age =75 years old 2)Have a need for colonoscopy screening 3)Sign a written informed consent 4)Have full capacity for civil conduct

Exclusion criteria

Exclusion criteria: 1) New myocardial infarction, cerebral infarction, pulmonary embolism, severe cardiac, liver, renal insufficiency, or mental illness within 6 months; 2) Taking aspirin, warfarin and other anticoagulants 3) Individuals with inflammatory bowel disease, polyposis coli, familial polyposis, or diagnosed or highly suspected colon cancer 4) Individuals with a history of colectomy 5) Pregnancy women 6) Subjects participating in clinical trials of other drugs or medical devices 7) Participants who were unsuitable for this clinical trial

Design outcomes

Primary

MeasureTime frame
Sensitivity of colorectal polyps;Specificity of colorectal polyps;

Secondary

MeasureTime frame
false positive rate;false negative rate;positive predictive value;negative predictive value;positive likelihood ratio;negative likelihood ratio;

Countries

China

Contacts

Public ContactZhang Shutian

Beijing Friendship Hospital,Capital Medical University

zhangst@ccmu.edu.cn+86 139 1102 1992

Outcome results

None listed

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