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NCT05178095 Clinical Trial

Artificial Intelligence in Colonic Polyp Detection

Gastrointestinal Neoplasms Clinical Trial

Official title:
Artificial Intelligence in Colonic Polyp Detection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05178095
Other study ID # Dnr 2020-01951
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2020
Est. completion date June 1, 2023

Study information
Verified date June 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria: - All patients without IBD referred for colonoscopy Exclusion Criteria: - Age < 40 years - Not willing to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Artificial intelligence
Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps
• No Artificial Intelligence
Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps

Locations
Country Name City State
Sweden Dr Per Hedenström Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary ADR Adenoma detection rate 1 hour
Secondary APC Adenomas per colonoscopy 1 hour
Secondary Procedural time The number of minutes required to complete the colonoscopy withdrawal 1 hour
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