NCT04196088

To Compare Artificial Intelligence Software Aided Adenoma Detection in Screening Colonoscopies Versus Standard Colonoscopy Without Artificial Intelligence Software Assistance in Participants Between 45 and 75 Years of Age

AIDA: A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Artificial Intelligence (AI) Detection of Adenomas (AIDA) With Standard High Definition With Light in Screening Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 978 (estimated)
• Sponsor: Docbot, Inc. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the efficacy of Ultivision Artificial Intelligence (AI) Software in detecting adenomas in screening colonoscopy procedures. The safety of Ultivision AI Software will also be assessed. A subset of the subjects will enter a roll-in period for clinical trial safety assessment. The remainder of subjects who are eligible will enter the detection phase which comprises a screening colonoscopy procedure. In the detection phase, subjects will be randomized to a screening colonoscopy with Ultivision AI Software enhancement or without AI Software enhancement. The study will measure the mean adenomas per colonoscopy procedure, as defined by the protocol, detected while receiving either treatment option.

Conditions

• Colorectal Adenoma
• Colorectal Polyp
• Colorectal Adenocarcinoma
• Colorectal SSA

Interventions

Type	Name	Description
DEVICE	Ultivision Artificial Intelligence Software	Screening Colonoscopy
DEVICE	No Artificial Intelligence Software enhancement	Screening Colonoscopy

Timeline

• Start date: 2020-06-11
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2019-12-12
• Last updated: 2021-03-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study