Adenoma Colon
Conditions
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.
Interventions
DEVICEAI-assisted colonoscopy
AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma detection rate | up to 2months | The proportion of patients with at least one histologically proven adenoma or carcinoma |
| withdrawal time compliance rate | up to 2months | The proportion of patients with clean withdrawal time \>6min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| polyp detection rate | up to 2 months | The proportion of patients with at least one polyp. |
| adenoma per colonoscopy | up to 2 months | The number of adenomas detected per colonoscopy |
| polyp per colonoscopy | up to 2 months | The number of polys detected per colonoscopy |
Countries
China
Outcome results
None listed