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To evaluate the prospective, multi-center, cross-controlled clinical study of gastrointestinal endoscopic imaging software for colorectal polyp diagnosis

To evaluate the prospective, multi-center, cross-controlled clinical study of gastrointestinal endoscopic imaging software for colorectal polyp diagnosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081316
Enrollment
Unknown
Registered
2024-02-28
Start date
2024-03-10
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Colorectal polyp

Interventions

experimental group:The subjects first performed the gastrointestinal endoscopy and colorectal polyp assisted detection software to assist the researchers in electronic colonoscopy, and then performed
control group:The subjects first underwent routine electronic colonoscopy, and then the gastrointestinal endoscopic image colorectal polyp assisted detection software assisted the researchers to perfo

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria to be enrolled in the study: 1) 18 years old = age =70 years old, gender is not limited; 2) Subjects with electronic colonoscopy diagnosis and screening needs; 3) Signed written informed consent; 4) A person with full capacity for public action.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1) Have a history of acute myocardial infarction (within 6 months), have serious heart, liver, kidney dysfunction, or mental disorders; 2) Those who have taken aspirin, warfarin and other anticoagulants within the past 5 days; 3) Re-examination of inflammatory bowel disease and colorectal polyposis confirmed or highly suspected colon cancer; 4) Subjects with a history of colectomy; 5) Patients with familial colorectal polyposis; 6) Pregnant women; 7) Subjects who are participating in clinical trials of other drugs or medical devices; 8) Subjects deemed unsuitable for this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Polyp detection rate at first test;

Secondary

MeasureTime frame
Mean polyp number;Polyp missed rate;The ileocecal area reached blindness rate;Exit time;Intestinal cleanliness score;

Countries

China

Contacts

Public ContactHe Song

The Second Affiliated Hospital of Chongqing Medical University

hedoctor65@sina.com+86 23 6369 3746

Outcome results

None listed

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