Prospective observational study on data collection in lower gastrointestinal endoscopy and development of image diagnosis support software using artificial intelligence (AI)

JRCT ID: jRCT1030230661

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients scheduled for lower gastrointestinal endoscopy or treatment
• Date of first enrollment: 13/06/2024
• Target sample size: 6600
• Study type: Observational

Outcome(s)

• Primary Outcome: (1) Sensitivity of AI for lesions with a diameter of 10 mm or less

Secondary Outcome

(1) Specificity of AI for lesions with a diameter of 10 mm or less
(2) Positive predictive value of AI for lesions with a diameter of 10 mm or less
(3) Negative predictive value of AI for lesions with a diameter of 10 mm or less

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients scheduled for lower gastrointestinal endoscopy or treatment
(2) Patients who are 18 years or older at the time of obtaining consent
(3) Patients who can consent to participate in this study by signing a document

• Exclude criteria: (1)Patients judged by the principal investigator or co-investigator to be unsuitable as subjects for this study

Related Information

• Primary Sponsor: Tada Tomohiro