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Clinical Trials/NCT05941689
NCT05941689
Completed
Not Applicable

Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System

Xiangya Hospital of Central South University2 sites in 1 country1,906 target enrollmentJuly 25, 2023
ConditionsAdenoma Colon

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenoma Colon
Sponsor
Xiangya Hospital of Central South University
Enrollment
1906
Locations
2
Primary Endpoint
adenoma detection rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.

Registry
clinicaltrials.gov
Start Date
July 25, 2023
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xiangya Hospital of Central South University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who need to undergo colonoscopy. -

Exclusion Criteria

  • Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.

Outcomes

Primary Outcomes

adenoma detection rate

Time Frame: up to 2months

The proportion of patients with at least one histologically proven adenoma or carcinoma

withdrawal time compliance rate

Time Frame: up to 2months

The proportion of patients with clean withdrawal time \>6min.

Secondary Outcomes

  • adenoma per colonoscopy(up to 2 months)
  • polyp per colonoscopy(up to 2 months)
  • polyp detection rate(up to 2 months)

Study Sites (2)

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