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Completed

NCT Number: NCT05141773

Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

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.

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Key information

Conditions

Adenoma Detection Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, SANTA CRUZ DE TENERIFE, 38320, Spain

About this study

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.

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 antiaggregants that contraindicate the performance of therapy
  • Patients with a recent colonoscopy (<6 months) of good quality (e.g. cited for endoscopic therapy)
  • IBD
  • 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

Treatment and study plan

Computed adenoma detection system (CADe) plus endocuff

Device

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

endocuff

Device

An add-on device (Endocuff) is also incorporated to the tip of the colonoscope

Primary outcomes

  1. Adenoma detection rate

    Time frame: 1 year

    (number of colonoscopies with adenoma/number of colonoscopies)

Secondary outcomes

  1. Serrated detection rate

    Time frame: 1 year

    (number of colonoscopies with serrated adenoma/number of colonoscopies)

  2. Advanced adenoma detection rate

    Time frame: 1 year

    (number of colonoscopies with advanced adenomas/number of colonoscopies)

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Registry information

Official study title

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

Acronym: CUFFAID

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2021
Registry last updated
Jul 24, 2025

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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