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Spots Global Cancer Trial Database for Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

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Trial Identification

Brief Title: Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

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

Study ID: NCT05141773

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Antonio Z García, MD, PhD

Affiliation: Hospital Universitario de Canarias

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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