Artificial Intelligence Aid Systems in Colorectal Adenoma Detection

Status Completed

Clinical Trial Summary

The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. The secondary aims were: - To evaluate the benefit of Endo-AID 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.

Clinical Trial Description

Priority guidelines have been established regarding IA 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 in endoscopists with different adenoma detection rates. In addition, there are no studies with the recent CADe Endo-AID system (Olympus Corp. Tokyo). The main purpose of the study to evaluate the usefulness of the Endo-AID artificial intelligence system in the detection of colorectal adenomas in consecutive patients for outpatient colonoscopy. 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 four groups: CADe system and high ADR endoscopist; CADe system and low ADR endoscopist; Control and high ADR endoscopist; Control and low ADR endoscopist. For the sample size calculation a 14.4 of difference in favor of the CADe system was considered. Taking onto account an alpha error of 0.05 in a unilateral contrast, a power of 80% and a loss of 10%, 165 patients per group would be required. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04945044
Study type	Interventional
Source	Hospital Universitario de Canarias
Contact
Status	Completed
Phase	N/A
Start date	November 15, 2021
Completion date	January 31, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442738` - A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)
Completed	`NCT03041532` - Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme	N/A
Not yet recruiting	`NCT05141773` - Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection	N/A
Completed	`NCT03137277` - A Study Between Two Instrument Generations to Improve Adenoma Detection in Screening Colonoscopy
Recruiting	`NCT05125939` - Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
Recruiting	`NCT05863208` - Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision	N/A
Completed	`NCT04472741` - Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice	N/A
Recruiting	`NCT04963010` - Impact of SFV of Proximal Colon on ADR	N/A
Completed	`NCT04086706` - Retroflexion In The Ascending Colon Is A Costless Endoscopic Maneuver Increasing Adenoma Detection Rate
Not yet recruiting	`NCT03185299` - Impact of Reinforced Education by Video on the Quality of Bowel Preparation	N/A
Completed	`NCT02507037` - Effect of Gum Chewing on Bowel Cleansing Before Colonoscopy	Phase 4
Completed	`NCT02540239` - Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy	N/A
Completed	`NCT04397120` - The Factors Affecting ADR of Screening Colonoscopy
Completed	`NCT01786213` - Training Effects in Colonoscopy	N/A
Completed	`NCT06173297` - Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.
Not yet recruiting	`NCT03356015` - Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation	Phase 4
Not yet recruiting	`NCT03352700` - Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy	Phase 4
Recruiting	`NCT04102631` - A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy	N/A
Not yet recruiting	`NCT02832869` - Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Artificial Intelligence Aid Systems in Colorectal Adenoma Detection — INTELAID

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms