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Colorectal NeoplasmsCADeNCENCT05888623

Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation

An observational study of Colorectal Neoplasms, run by VA Puget Sound Health Care System at 1 site in United States.

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 goal of this cluster randomized study is to determine if artificial intelligence systems used during colonoscopy can improve the detection of precancerous polyps in the colon. Read more about this study

Who is it for?
Any age
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Computer Assisted Detection
Type of treatment
Medical device
How many people
334,200 participants
Where
1 siteUnited States
Study dates
1 Oct 2022to 31 Dec 2023
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Veterans undergoing colonoscopy for any indication at VA facilities across the United States.

Who may be able to join

  • Colonoscopy performed at a Veterans Affairs (VA) medical center

Who cannot join

  • Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment
  • Colonoscopy performed at a VA medical center where pathology results are not available

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: Computer Assisted Detection of Neoplasia During Colonoscopy Evaluation (CADeNCE)

The goal of this cluster randomized study is to determine if artificial intelligence systems used during colonoscopy can improve the detection of precancerous polyps in the colon. The primary question it aims to answer is whether computer-assisted detection devices improve the proportion of colonoscopies found to have precancerous adenomatous polyps.

Secondary aims will assess if computer-assisted detection devices improve the proportion of colonoscopies found to other types of precancerous polyps known as sessile serrated lesions, or cancer of the colon and rectum. The study will also assess possible negative effects of use of computer-assisted detection (e.g., prolonging the procedure time or false-positive biopsies) and survey device users to learn about their experience with this technology.

Read more

The study team will provide computer-assisted detection devices to randomly chosen VA medical centers for use during colonoscopy and compare colonoscopy findings for patients who undergo colonoscopy at facilities that are equipped with these devices to the findings of patients who undergo colonoscopy at VA facilities that do not have these devices.

A survey will be distributed to physicians who perform colonoscopy to assess their experience using computer-assisted detection devices.

Being tested
Computer Assisted Detection
Keywords
colonoscopy, artificial intelligence, adenoma, Veterans, quality assurance
Medical subject headings
Colorectal Neoplasms, Adenoma

What participants receive

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

  • Computer Assisted DetectionDevice

    Also called GI Genius Intelligent Endoscopy Module (Medtronic)

    Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy

Study groups in NCT05888623
Study groupRoleWhat they receive
Computer Assisted DetectionColonoscopies performed at a VA facility with computer assisted detection (CADe) artificial intelligence available.
Receives: Device: Computer Assisted Detection
Conventional ColonoscopyColonoscopies performed at a VA facility without CADe artificial intelligence available

What is being measured

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

  1. Adenoma Detection Rate

    Change in the proportion of colonoscopies in which one or more adenomas are detected

    Measured: Baseline and 6 months

Secondary outcomes (6)

  1. Adenocarcinoma detection rate

    Change in the proportion of colonoscopies where colorectal cancer is detected

    Measured: Baseline and 6 months

  2. Sessile serrated lesion detection rate

    Proportion of colonoscopies with one or more sessile serrated lesions detected

    Measured: Baseline and 6 months

  3. Proportion of colonoscopies with pathology obtained

    Proportion of colonoscopies where specimens were obtained for pathologic review

    Measured: Baseline and 6 months

  4. Proportion of pathology without adenoma or adenocarcinoma

    As a surrogate for false positive lesion identification during use of CADe

    Measured: Baseline and 6 months

  5. Withdrawal time without interventions

    Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed. This outcome can only be assessed at a subset of sites due to data availability issues (i.e., Provation MD sites).

    Measured: Baseline and 6 months

  6. Provider satisfaction with computer assisted detection for colonoscopy

    Provider ratings of satisfaction with the CADe device

    Measured: Approximately 6 months after deployment

Timeline

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

  1. First posted5 Jun 2023
  2. Study start1 Oct 2022
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
334,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05888623
Sponsor's protocol ID
VHA_NGHP_001
Acronym
CADeNCE
Status last verified
Oct 2025
First submitted
15 May 2023
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Levy I, Bruckmayer L, Klang E, Ben-Horin S, Kopylov U. Artificial Intelligence-Aided Colonoscopy Does Not Increase Adenoma Detection Rate in Routine Clinical Practice. Am J Gastroenterol. 2022 Nov 1;117(11):1871-1873. doi: 10.14309/ajg.0000000000001970. Epub 2022 Aug 23.

    PubMed 36001408

  • Ladabaum U, Shepard J, Weng Y, Desai M, Singer SJ, Mannalithara A. Computer-aided Detection of Polyps Does Not Improve Colonoscopist Performance in a Pragmatic Implementation Trial. Gastroenterology. 2023 Mar;164(3):481-483.e6. doi: 10.1053/j.gastro.2022.12.004. Epub 2022 Dec 15. No abstract available.

    PubMed 36528131

  • Wallace MB, Sharma P, Bhandari P, East J, Antonelli G, Lorenzetti R, Vieth M, Speranza I, Spadaccini M, Desai M, Lukens FJ, Babameto G, Batista D, Singh D, Palmer W, Ramirez F, Palmer R, Lunsford T, Ruff K, Bird-Liebermann E, Ciofoaia V, Arndtz S, Cangemi D, Puddick K, Derfus G, Johal AS, Barawi M, Longo L, Moro L, Repici A, Hassan C. Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007. Epub 2022 Mar 15.

    PubMed 35304117

  • 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

  • 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

  • Gawron AJ, Yao Y, Gupta S, Cole G, Whooley MA, Dominitz JA, Kaltenbach T. Simplifying Measurement of Adenoma Detection Rates for Colonoscopy. Dig Dis Sci. 2021 Sep;66(9):3149-3155. doi: 10.1007/s10620-020-06627-2. Epub 2020 Oct 8.

    PubMed 33029706

  • Dominitz JA, Gawron AJ, McKee GB, Hoggatt KJ, Kaltenbach T. Impact of Availability of Computer-Aided Detection Devices on Adenoma Detection During Colonoscopy: A Cluster Randomized Study. Gastroenterology. 2026 Jun 5:S0016-5085(26)06941-6. doi: 10.1053/j.gastro.2026.05.018. Online ahead of print.

    PubMed 42250891

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms, run by VA Puget Sound Health Care System at 1 site in United States.

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 1 inclusion and 2 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 14 Oct 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 United States. 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: Baseline and 6 months). 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 NCT05888623, 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 14 Oct 2025.

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