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Efficacy and safety evaluation of real-time assisted diagnosis system for digestive endoscopy

Efficacy and safety evaluation of real-time assisted diagnosis system for digestive endoscopy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026001
Enrollment
Unknown
Registered
2019-09-17
Start date
2019-06-15
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

protruding-type lesions in the upper digestive tract (esophagus, stomach, duodenum) and lower digestive tract (colorectal). In addition to digestive tract-lifting new organisms, this product does not

Interventions

Gold Standard:Physician's diagnosis
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endoscopy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Aged 18 to 80 years old male and female; 3. Patients have indications for digestive endoscopy; 4. Patients are able to communicate well with the researcher and comply with the entire test requirements.

Exclusion criteria

Exclusion criteria: 1) Patients have contraindications for digestive endoscopy; 2) Those with high risk of complications such as digestive endoscopy, such as unstable heart and lung function, active bleeding, obstruction and suspected gastrointestinal perforation; 3) Patients with severe mental disorders 4) lactating, pregnant women; 5) Poor compliance, unwillingness or inability to follow the test plan requirements; 6) Other investigators believe that it is not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Target lesion detection rate: In the clinical endoscopic operation of detecting protruding-type lesions, the difference in the detection speed of the endoscopic physician and the digestive endoscopic real-time auxiliary diagnosis system was compared.;

Secondary

MeasureTime frame
Target lesion detection rate: In the clinical endoscopic operation of detecting protruding-type lesions, whether the digestive endoscopic physician found the lesion as a standard control, and determine the detection rate of the elevated neoplasm by the real-time auxiliary diagnostic system of digestive endoscopy SEN, SPE;

Countries

China

Contacts

Public ContactTang Chengwei
shcqcdmed@163.com+86 18980601275

Outcome results

None listed

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