ClinicalTrials.gg
Not yet recruitingNCT07814274PSIUSADUpdated Sep 10, 2026

Prospective Intestinal Ultrasound Study for Artificial Intelligence Algorithm Development

An observational study in Inflammatory Bowel Disease (IBD), sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by University of British Columbia · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
95
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Inflammatory Bowel Diseases by University of British Columbia — 5 open to participants now, 5 under way, none of them phase 3. Inflammatory Bowel Diseases · University of British Columbia.

Started
2026
with 3 others
Observational
6 of 12
3 open now
Registered
12th of 12
by date

Among the 12 studies in Inflammatory Bowel Diseases by University of British Columbia, this one is one of 4 that started in 2026, is one of 6 observational ones, and was the 12th registered.

Inflammatory Bowel Diseases

1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.

Browse Inflammatory Bowel Diseases studies →

Open to participants now

5 of the 12 studies in Inflammatory Bowel Diseases by University of British Columbia are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Inflammatory Bowel Diseases by University of British Columbia, or all of them as a file.
02

Study summary

This observational study will use intestinal ultrasound images to help develop computer programs that may make it easier to assess bowel inflammation.

The study will include adults who are healthy or who are having an intestinal ultrasound as part of care for inflammatory bowel disease, such as Crohn disease or ulcerative colitis. Researchers want to find out whether a computer program can measure bowel wall thickness from ultrasound images as accurately as experienced ultrasound clinicians. They will also explore whether the program can identify other changes in the bowel.

Participants will have an intestinal ultrasound as part of their usual care. People who agree to take part will allow the research team to use de-identified ultrasound images and a small amount of related health information. No medication, experimental treatment, or additional ultrasound procedure will be given for this study. The computer program will not be used to make decisions about a participant's care, and participants will not receive individual results from the program.

Read the detailed description

Inflammatory bowel disease, including Crohn disease and ulcerative colitis, requires reliable assessment of intestinal inflammation to support clinical monitoring and treatment decisions. Intestinal ultrasound is a non-invasive, point-of-care imaging method that can assess bowel inflammation without radiation exposure. However, its interpretation may vary by operator experience and local scanning practice.

This prospective, multicentre, observational study will collect de-identified intestinal ultrasound images, cine loops, and limited associated metadata from adults aged 18 years and older. Eligible participants may be healthy individuals with no known inflammatory bowel disease or individuals undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason. Intestinal ultrasound examinations will be performed as part of routine clinical care. The study does not add a treatment intervention, investigational drug, experimental device, or clinically directed diagnostic procedure.

Following informed consent, ultrasound images and cine loops generated during the routine examination will be exported in de-identified DICOM format. Limited information relevant to artificial intelligence development and validation, such as age, sex, self-reported race, pregnancy status, eligibility confirmation, and relevant scan-related or pre-existing clinical information, may also be recorded. Direct personal identifiers and personal health information will be removed before the data are transferred outside the clinical site.

The de-identified data will be reviewed for appropriate de-identification and formatting before secure transfer to Dova Health Intelligence Inc. The data will be annotated and used to develop, train, tune, and test computer vision algorithms designed to identify bowel structures and measure bowel wall thickness on intestinal ultrasound. The study will also assess the feasibility of developing algorithms to evaluate bowel wall layer stratification, luminal diameter, bowel wall flow, bowel wall scarring, gastrointestinal motility, and mesenteric fat proliferation.

The primary objective is to evaluate whether the computer vision algorithm prototype can measure bowel wall thickness with performance comparable to manual measurements by experienced sonographers. Secondary objectives include evaluating the quality, diversity, and usability of the collected ultrasound data for artificial intelligence development and assessing the feasibility of measuring additional intestinal ultrasound features.

The algorithms developed in this study are investigational and will not be used in routine clinical care during the study. No participant-level algorithm findings will be returned to participants, and participation is not expected to provide a direct clinical benefit. The primary foreseeable risk is a loss of confidentiality; this risk is mitigated through de-identification at the study site, verification of de-identification before transfer, secure file transfer, controlled access, and secure cloud-based storage. The study plans to enroll up to 95 participants internationally, including up to 30 participants at the British Columbia site.

03

Conditions studied

  • Inflammatory Bowel Disease (IBD)

Keywords

  • Intestinal Ultrasound
  • Artificial Intelligence
  • Machine Learning
  • Bowel Wall Thickness
  • Crohn Disease
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
  • Ultrasound
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will consist of adults aged 18 years and older who are either healthy or undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason. Participants will be recruited through the IBD Centre of BC and other participating study sites. The study may include individuals with inflammatory bowel disease and healthy volunteers. The study aims to include a diverse participant population to support evaluation of artificial intelligence algorithm performance across different participant characteristics.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older.
  • Individuals who are either healthy with no known finding of inflammatory bowel disease before the ultrasound examination or undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason.
  • Individuals who are able and willing to provide for the collection and use of de-identified study data.

Exclusion criteria

Exclusion Criteria:

  • Individuals who do not meet the study demographic requirements.
  • Individuals unable or unwilling to provide .
  • Pregnant individuals.
  • Individuals with health conditions managed using drugs or medical-device intervention, or with unmanaged conditions or conditions requiring monitoring, that could affect study eligibility or the ultrasound assessment.
  • Individuals who have recently taken contrast-enhancing compounds.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
95 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intestinal Ultrasound Participants

    This cohort includes adults aged 18 years and older who are either healthy or undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason. Participants will undergo intestinal ultrasound as part of routine clinical care. With informed consent, de-identified ultrasound images and cine loops, along with limited associated information such as age, sex, self-reported race, and relevant scan-related details, will be collected for artificial intelligence algorithm development. No study drug, experimental treatment, or experimental device will be administered. The artificial intelligence algorithms will not be used to guide participant care or provide individual diagnostic results during the study.

    Other: De-identified Intestinal Ultrasound Data Collection

Interventions

  • OtherDe-identified Intestinal Ultrasound Data Collection

    Intestinal ultrasound images and cine loops will be collected from adults undergoing ultrasound as part of routine clinical care. Following informed consent, the images and cine loops will be de-identified and used for artificial intelligence algorithm development, training, tuning, and testing. The study does not assign participants to receive an intervention, and the ultrasound is not performed solely for research purposes. The artificial intelligence algorithms developed using the data will not be used to guide participant care or provide individual diagnostic results during the study.

06

What researchers measure

Primary outcomes

  1. Artificial Intelligence-Generated Bowel Wall Thickness Measurement Agreement

    Agreement between bowel wall thickness measurements generated by the artificial intelligence computer-vision algorithm and manual bowel wall thickness measurements performed by experienced sonographers using de-identified intestinal ultrasound images and cine loops. Agreement will be assessed using the pre-specified performance metric in the statistical analysis plan.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

Secondary outcomes

  1. Bowel Wall Layer Stratification Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall layer stratification.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  2. Luminal Diameter Measurement Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable luminal diameter measurement.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  3. Bowel Wall Flow Assessment Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall flow assessment.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  4. Bowel Wall Scarring Assessment Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall scarring assessment.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  5. Gastrointestinal Motility Assessment Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable gastrointestinal motility assessment.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  6. Mesenteric Fat Proliferation Assessment Feasibility

    Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable assessment of mesenteric fat proliferation.

    Time frame: Day 1, after completion of the intestinal ultrasound examination

  7. Proportion of Cine Loops Suitable for AI Development

    Percentage of collected de-identified cine loops that meet all pre-specified completeness, image-quality, and required-metadata criteria for artificial intelligence algorithm training, tuning, and testing.

    Time frame: At completion of dataset preparation

07

Study locations

1 site
  • IBD Centre of BC
    Vancouver, British Columbia V6Z 2L2, Canada
08

References and documents

Publications

  • Jauregui-Amezaga A, Rimola J. Role of Intestinal Ultrasound in the Management of Patients with Inflammatory Bowel Disease. Life (Basel). 2021 Jun 23;11(7):603. doi: 10.3390/life11070603. PubMed 34201630 ↗
  • Frias-Gomes C, Torres J, Palmela C. Intestinal Ultrasound in Inflammatory Bowel Disease: A Valuable and Increasingly Important Tool. GE Port J Gastroenterol. 2021 Nov 23;29(4):223-239. doi: 10.1159/000520212. eCollection 2022 Jul. PubMed 35979252 ↗
  • Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216. PubMed 33098642 ↗
  • Goodsall TM, Nguyen TM, Parker CE, Ma C, Andrews JM, Jairath V, Bryant RV. Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease. J Crohns Colitis. 2021 Jan 13;15(1):125-142. doi: 10.1093/ecco-jcc/jjaa129. PubMed 32614386 ↗

Individual participant data

Plan to share: No — Individual participant-level data will not be made available to external researchers. The study will collect de-identified intestinal ultrasound images, cine loops, and limited associated information for use by Dova Health Intelligence Inc. in quality assessment, annotation, artificial intelligence algorithm training, tuning, testing, and related future algorithm-development activities described in the study protocol. Data will not be made publicly available or shared outside the authorized study collaborators.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 4 months later.

Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 4 months is below that.

Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 10, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07814274
Collaborators
IBD Centre of BC, Providence Health Care Ventures, Dova Health Intelligence Inc
Responsible party
Matthew Smyth (Assistant Clinical Professor, University of British Columbia) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Cristian A Massaro, MSc
Contact
iusresearch@ibdcentrebc.ca
587-223-5248
Matthew J Smyth, MD
principal investigator · University of British Columbia, IBD Centre of BC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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