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Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05718193
Enrollment
2868
Registered
2023-02-08
Start date
2022-06-01
Completion date
2023-03-15
Last updated
2023-04-11

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

Conditions

Artificial Intelligence, Colonoscopy, Quality Control

Brief summary

To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.

Interventions

DIAGNOSTIC_TESTDeFrame

The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.

DIAGNOSTIC_TESTClassified DeFrame

The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.

conventional colonoscopy

Sponsors

Loudi Central Hospital
CollaboratorOTHER
Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.

Exclusion criteria

History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.

Design outcomes

Primary

MeasureTime frameDescription
adenoma detection rateup to 9 monthsPercentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.
adenomas per colonoscopyup to 9 monthsTotal number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026