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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05990218
Other study ID # 031/2566
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 13, 2023
Est. completion date February 28, 2026

Study information

Verified date August 2023
Source Rajavithi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Colonoscopy is the gold standard modality for the detection of colonic polyp. However, miss polyp occurs especially in right sided colon. Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited. This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date February 28, 2026
Est. primary completion date February 12, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - participants age 40-80 years Exclusion Criteria: - History of colonic surgery (except appendectomy) - Lower gastrointestinal bleeding - unstable vital sign during endoscopy of pregnancy - history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Artificial intellegence. CADe syste,
The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.
control
The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.

Locations

Country Name City State
Thailand Rajavithi Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Kamba S, Tamai N, Saitoh I, Matsui H, Horiuchi H, Kobayashi M, Sakamoto T, Ego M, Fukuda A, Tonouchi A, Shimahara Y, Nishikawa M, Nishino H, Saito Y, Sumiyama K. Reducing adenoma miss rate of colonoscopy assisted by artificial intelligence: a multicenter randomized controlled trial. J Gastroenterol. 2021 Aug;56(8):746-757. doi: 10.1007/s00535-021-01808-w. Epub 2021 Jul 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary polyp detection rate the number of polyp detected during endoscopy during endoscopy
Secondary type of polyp the type of polyp detected during endoscopy during endoscopy
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