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Adenoma Detection RateINTELAIDNCT04945044

Artificial Intelligence Aid Systems in Colorectal Adenoma Detection

A study testing Computed adenoma detection system (CADe) in people with Adenoma Detection Rate, run by Hospital Universitario de Canarias at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenoma Detection Rate
What is being tested?
Computed adenoma detection system (CADe)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteSpain
Study dates
15 Nov 2021to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Gastroenterology

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

Other trials in Spain

About this study

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

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.
Read the detailed 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.

Being tested
Computed adenoma detection system (CADe), Control group (regular colonoscopy)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)Behavioural

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

Study groups in NCT04945044
Study groupRoleWhat they receive
Computed adenoma detection system (CADe)ExperimentalTis system can detect in the screen suspicion areas of adenomatous polyps. This is an additional help for the endoscopist for the detection of lesions
Receives: Device: Computed adenoma detection system (CADe)
Control group (absence of CADe)Active comparatorThis is the control group. As in the routine colonoscopy the endoscopist is in charge of the detection of the lesions.
Receives: Behavioral: Control group (regular colonoscopy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma detection rate

    Number of colonoscopies with colorectal adenoma/Number of total colonoscopies

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

Secondary outcomes (2)

  1. Serrated detection rate

    Number of colonoscopies with serrated adenoma/Number of total colonoscopies

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

  2. Advanced adenoma detection rate

    Number of colonoscopies with advanced adenoma/Number of total colonoscopies

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start15 Nov 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04945044
Sponsor's protocol ID
Computer aid adenoma detection
Acronym
INTELAID
Status last verified
Sep 2022
First submitted
22 Jun 2021
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.

    PubMed 32598963

  • Berzin TM, Parasa S, Wallace MB, Gross SA, Repici A, Sharma P. Position statement on priorities for artificial intelligence in GI endoscopy: a report by the ASGE Task Force. Gastrointest Endosc. 2020 Oct;92(4):951-959. doi: 10.1016/j.gie.2020.06.035. Epub 2020 Jun 19.

    PubMed 32565188

  • Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22.

    PubMed 31981517

  • Wang P, Liu P, Glissen Brown JR, Berzin TM, Zhou G, Lei S, Liu X, Li L, Xiao X. Lower Adenoma Miss Rate of Computer-Aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study. Gastroenterology. 2020 Oct;159(4):1252-1261.e5. doi: 10.1053/j.gastro.2020.06.023. Epub 2020 Jun 17.

    PubMed 32562721

  • Gimeno-Garcia AZ, Hernandez Negrin D, Hernandez A, Nicolas-Perez D, Rodriguez E, Montesdeoca C, Alarcon O, Romero R, Baute Dorta JL, Cedres Y, Castillo RD, Jimenez A, Felipe V, Morales D, Ortega J, Reygosa C, Quintero E, Hernandez-Guerra M. Usefulness of a novel computer-aided detection system for colorectal neoplasia: a randomized controlled trial. Gastrointest Endosc. 2023 Mar;97(3):528-536.e1. doi: 10.1016/j.gie.2022.09.029. Epub 2022 Oct 11.

    PubMed 36228695

Questions about this trial

What is this clinical trial studying?

A study testing Computed adenoma detection system (CADe) in people with Adenoma Detection Rate, run by Hospital Universitario de Canarias at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma detection rate (time frame: [Time frame: 1 years][Designated as safety issue: No]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04945044, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

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