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Completed

NCT Number: NCT04945044

Artificial Intelligence Aid Systems in Colorectal Adenoma Detection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Patients referred for outpatient colonoscopy

Exclusion criteria

  • Colonic resection
  • Taking anticoagulants or antiagregants that contraindicate the performance of therapy
  • Patients with a recent colonoscopy (<6 months) of good quality (e.g. cited for endoscopic therapy)
  • Inflammatory bowel disease
  • Patients with incomplete colonoscopy
  • Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
  • Patients with polyposis syndromes
  • Refusal to participate in the study.

Treatment and study plan

Computed adenoma detection system (CADe)

Device

This is a computed system that helps the endoscopist to increase the detection of colorectal polyps

Control group (regular colonoscopy)

Behavioral

It is exclusively the endoscopist in charge of the detection of the polyps (usual practice)

Primary outcomes

  1. Adenoma detection rate

    Time frame: [Time frame: 1 years][Designated as safety issue: No]

    Number of colonoscopies with colorectal adenoma/Number of total colonoscopies

Secondary outcomes

  1. Serrated detection rate

    Time frame: [Time Frame: 1 years][Designated as safety issue: No]

    Number of colonoscopies with serrated adenoma/Number of total colonoscopies

  2. Advanced adenoma detection rate

    Time frame: [Time Frame: 1 years][Designated as safety issue: No]

    Number of colonoscopies with advanced adenoma/Number of total colonoscopies

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Registry information

Official study title

Usefulness of the Endo-AID Artificial Intelligence System in the Detection of Colorectal Adenomas. a Randomized Controlled Trial

Acronym: INTELAID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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