Prospective Intestinal Ultrasound Study for Artificial Intelligence Algorithm Development

NCT07814274 | Not Yet Recruiting

• 1 other identifier: H26-00188
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

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

Outcome Measures

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.

  Day 1, after completion of the intestinal ultrasound examination

Secondary Outcomes (7)

• Bowel Wall Layer Stratification Feasibility

  Day 1, after completion of the intestinal ultrasound examination

• Luminal Diameter Measurement Feasibility

  Day 1, after completion of the intestinal ultrasound examination

• Bowel Wall Flow Assessment Feasibility

  Day 1, after completion of the intestinal ultrasound examination

• Bowel Wall Scarring Assessment Feasibility

  Day 1, after completion of the intestinal ultrasound examination

• Gastrointestinal Motility Assessment Feasibility

  Day 1, after completion of the intestinal ultrasound examination

Study Arms (1)

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

De-identified Intestinal Ultrasound Data Collection OTHER

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.

Intestinal Ultrasound Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 informed consent for the collection and use of de-identified study data.

You may not qualify if:

• Individuals who do not meet the study demographic requirements.
• Individuals unable or unwilling to provide informed consent.
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• IBD Centre of BC: collaborator
• Providence Health Care Ventures: collaborator
• Dova Health Intelligence Inc: collaborator

Study Sites (1)

IBD Centre of BC

Vancouver, British Columbia, V6Z 2L2, Canada

Location

Related Publications (4)

• 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.

  PMID: 34201630 BACKGROUND

• 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.

  PMID: 35979252 BACKGROUND

• 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.

  PMID: 33098642 BACKGROUND

• 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.

  PMID: 32614386 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Matthew J Smyth, MD

  University of British Columbia, IBD Centre of BC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian A Massaro, MSc

CONTACT

587-223-5248; iusresearch@ibdcentrebc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)