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OpenTrials
Completed

NCT Number: NCT05718193

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

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

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Key information

Conditions

Artificial Intelligence Colonoscopy Quality Control

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya Hospital Central South University, Changsha, Hunan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DeFrame

Diagnostic Test

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.

Classified DeFrame

Diagnostic Test

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

Diagnostic Test

conventional colonoscopy

Primary outcomes

  1. adenoma detection rate

    Time frame: up to 9 months

    Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.

  2. adenomas per colonoscopy

    Time frame: up to 9 months

    Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Collaborators

  • Loudi Central Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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