NCT05141773

Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

Computer-assisted Adenoma Detection Coloscopy With Endo-AID Artificial Intelligence System and Endocuff Versus Endocuff Assisted Colonoscopy: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system combined with endocuff compared with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. The secondary aims were: * To evaluate the benefit of Endo-AID and endocuff in adenoma detection rate by comparing endoscopists with high and low adenoma detection rate. * To evaluate serrated detection rate, advanced adenoma detection rate, adenoma detection rate according to the size (\<= 5mm, 6-9mm,\> = 10mm) and number of adenomas by colonoscopy. Stratification by location and morphology.

Detailed description

Guidelines have been established regarding artificial intelligence (AI) applied to gastrointestinal endoscopy. Regarding the priority uses for their development, there are applications that improve vision, placing computer-assisted lesion detection (CADe) as one of the most necessary priorities, given the importance of colorectal cancer screening (CRC) and post-polypectomy surveillance. The evaluation of these systems in different clinical practices and patient groups has been recommend. In this regard, studies in the western population are limited and have been carried out by expert endoscopists. It has not been evaluated comparing with other strategies such as add-on devices. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo). The main purpose of the study is to evaluate the usefulness of the Endo-AID artificial intelligence system with endocuff in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy compared with standard colonoscopy with endocuff. In addition, the benefit of the CADe system will be assessed according to the endoscopist ADR. A randomized controlled trial will be carried out in consecutive outpatients meeting the inclusion criteria and none of the exclusion criteria. Patients with be randomized to one of the two groups: CADe system with endocuff and standard colonoscopy with endocuff.

Conditions

• Adenoma Detection Rate

Interventions

Type	Name	Description
DEVICE	Computed adenoma detection system (CADe) plus endocuff	This is a computed system that helps the endoscopist to increase the detection of colorectal polyps. An add-on device (Endocuff) is also incorporated to the tip of the colonoscope
DEVICE	Endocuff	An add-on device (Endocuff) is also incorporated to the tip of the colonoscope

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2021-12-02
• Last updated: 2025-07-24

Locations

1 site across 1 country: Spain