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Adenoma Detection RateCUFFAIDNCT05141773

Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

A study testing Computed adenoma detection system (CADe) plus endocuff and Endocuff 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 combined with endocuff compared with endocuff 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) plus endocuff and Endocuff
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
1 siteSpain
Study dates
1 Nov 2022to 30 Apr 2023
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 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de Canarias

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

Other trials in Spain

About this study

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

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.
Read the 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.

Being tested
Computed adenoma detection system (CADe) plus endocuff, Endocuff

What participants receive

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

  • Computed adenoma detection system (CADe) plus endocuffDevice

    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

  • EndocuffDevice

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

Study groups in NCT05141773
Study groupRoleWhat they receive
Computed adenoma detection system (CADe) and EndocuffExperimentalCADe system can detect in the screen suspicion areas of adenomatous polyps. This is an additional help for the endoscopist for the detection of lesions. Endocuff increases the colonic surface examinated
Receives: Device: Computed adenoma detection system (CADe) plus endocuff
Control group (Endocuff)Active comparatorEndocuff increases the colonic surface examinated
Receives: Device: Endocuff

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 adenoma/number of colonoscopies)

    Measured: 1 year

Secondary outcomes (2)

  1. Serrated detection rate

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

    Measured: 1 year

  2. Advanced adenoma detection rate

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

    Measured: 1 year

Timeline

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

  1. First posted2 Dec 2021
  2. Study start1 Nov 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

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
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141773
Sponsor's protocol ID
Computer aid colonoscopy
Acronym
CUFFAID
Status last verified
Jul 2025
First submitted
19 Nov 2021
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.

    PubMed 29363535

  • Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1.

    PubMed 32371116

  • Aziz M, Haghbin H, Gangwani MK, Sharma S, Nawras Y, Khan Z, Chandan S, Mohan BP, Lee-Smith W, Nawras A. Efficacy of Endocuff Vision compared to first-generation Endocuff in adenoma detection rate and polyp detection rate in high-definition colonoscopy: a systematic review and network meta-analysis. Endosc Int Open. 2021 Jan;9(1):E41-E50. doi: 10.1055/a-1293-7327. Epub 2021 Jan 1.

    PubMed 33403235

  • Ashat M, Klair JS, Singh D, Murali AR, Krishnamoorthi R. Impact of real-time use of artificial intelligence in improving adenoma detection during colonoscopy: A systematic review and meta-analysis. Endosc Int Open. 2021 Apr;9(4):E513-E521. doi: 10.1055/a-1341-0457. Epub 2021 Mar 17.

    PubMed 33816771

  • Barua I, Vinsard DG, Jodal HC, Loberg M, Kalager M, Holme O, Misawa M, Bretthauer M, Mori Y. Artificial intelligence for polyp detection during colonoscopy: a systematic review and meta-analysis. Endoscopy. 2021 Mar;53(3):277-284. doi: 10.1055/a-1201-7165. Epub 2020 Sep 29.

    PubMed 32557490

  • 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

  • Gimeno-Garcia AZ, Hernandez A, Hernandez Negrin D, Rodriguez E, Lorenzo G, Mon J, Romero R, Jimenez A, Felipe V, Adrian Z, de la Barreda R, Ortega J, Cedres Y, Hernandez-Guerra M, Nicolas-Perez D. Computer-assisted adenoma detection colonoscopy with an ENDO-AID artificial intelligence system and Endocuff- versus Endocuff-assisted colonoscopy: A randomized controlled trial. Gastroenterol Hepatol. 2026 Apr 2:502757. doi: 10.1016/j.gastrohep.2026.502757. Online ahead of print. English, Spanish.

    PubMed 41935575

Questions about this trial

What is this clinical trial studying?

A study testing Computed adenoma detection system (CADe) plus endocuff and Endocuff 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 7 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 24 Jul 2025. 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: 1 year). 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 NCT05141773, which also lists 7 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 24 Jul 2025.

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