Artificial Intelligence Aid Systems and Endocuff in Colorectal Adenoma Detection

NCT05141773 | Completed

• 1 other identifier: Computer aid colonoscopy
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Adenoma Detection Rate

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  (number of colonoscopies with adenoma/number of colonoscopies)

  1 year

Secondary Outcomes (2)

• Serrated detection rate

  1 year

• Advanced adenoma detection rate

  1 year

Study Arms (2)

Computed adenoma detection system (CADe) and Endocuff

EXPERIMENTAL

CADe 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

Device: Computed adenoma detection system (CADe) plus endocuff

Control group (Endocuff)

ACTIVE COMPARATOR

Endocuff increases the colonic surface examinated

Device: Endocuff

Interventions

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

Computed adenoma detection system (CADe) and Endocuff

Endocuff DEVICE

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

Control group (Endocuff)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Hospital Universitario de Canarias

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

Location

Related Publications (6)

• 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.

  PMID: 29363535 BACKGROUND

• 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.

  PMID: 32371116 BACKGROUND

• 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.

  PMID: 33403235 BACKGROUND

• 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.

  PMID: 33816771 BACKGROUND

• 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.

  PMID: 32557490 BACKGROUND

• 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.

  PMID: 32598963 BACKGROUND

Study Officials

• Antonio Z García, MD, PhD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)