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OpenTrials
Completed

NCT Number: NCT05941689

Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

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.

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Key information

Conditions

Adenoma Colon

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

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.

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Treatment and study plan

AI-Assisted Colonoscopy

Device

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.

Primary outcomes

  1. adenoma detection rate

    Time frame: up to 2months

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

  2. withdrawal time compliance rate

    Time frame: up to 2months

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

Secondary outcomes

  1. polyp detection rate

    Time frame: up to 2 months

    The proportion of patients with at least one polyp.

  2. adenoma per colonoscopy

    Time frame: up to 2 months

    The number of adenomas detected per colonoscopy

  3. polyp per colonoscopy

    Time frame: up to 2 months

    The number of polys detected per colonoscopy

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2023
Registry last updated
Oct 10, 2023

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

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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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