The Utility of Hand-held Ultrasound Devices to Detect Bowel Wall Inflammatory Activity in Crohn's Disease

NCT06686589 | Not Yet Recruiting

• 1 other identifier: SHEBA-23-0523-DC-CTIL
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the major obstacles in implementing intestinal ultrasound services for inflammatory bowel disease (IBD) patients relates to the costs of acquiring ultrasound (US) machines. The costs of high-end (and higher levels of quality) US machines are considerable, and although large medical centers in developed countries can obtain US machines, smaller centers in rural areas, community centers and centers in undeveloped countries may struggle with the cost of the machines. The lack of availability of point-of-care intestinal ultrasound impedes the medical treatment IBD patients receive. Recently, new models of hand-held small ultrasound machines were introduced to the market by large ultrasound companies. These machines are affordable and are used mainly for point-of-care ultrasound exams. We hypothesize that if the image quality acquired by these machines is proven to be good enough for the detection of bowel inflammation and complications in Crohn's disease (CD) patients, the use of intestinal ultrasound can potentially increase, allowing better care for CD patients. Our idea is to compare the accuracy of various hand-held ultrasound devices to detect ultrasonographic signs of bowel inflammatory activity (especially increased bowel wall thickness) to that of high-end and premium US machines. The first part of the project will include examining the quality of 2 different hand-held US machines (GE VSCAN air and Philips Lumify) by 3 experienced ultra-sonographers. If the achieved level of accuracy for the detection of bowel wall inflammatory activity will be sufficient (AUC\>0.8), we aim to move to the second part of the project. This step focuses on hand-held US machines by gastroenterologists with various levels of IUS experience. Therefore, we aim to examine the accuracy of hand-held US machines for the detection of inflammatory activity by delivering the hand-held US machines to 10 GI specialists who completed the IBUS educational curriculum for IUS (at least module 1+2) with various levels of IUS expertise.

• Project Goal 1) To examine the capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.
• Strategy - Comparing various ultrasonographic signs of inflammation acquired by hand-held US machines to that acquired by high-end and premium US machines.
• Outcomes - Accuracy of hand-held ultrasound machines in the detection of bowel wall inflammatory activity The problem being addressed by the proposed project - Dissemination of IUS is limited due to the high costs of US machines. The use of affordable hand-held US machines for the detection of inflammatory activity will expand the IUS incorporation into the CD diagnosis, monitoring, and treatment approaches, improving patient outcomes. Significance/Impact The use of affordable and precise US machines will disseminate the use of IUS and expand the IUS incorporation into the diagnosis, monitoring, and treatment of CD, improving patient outcomes

Conditions

Crohn Disease (CD)

Keywords

Crohn disease; intestinal ultrasound; hand held ultrasound

Outcome Measures

Primary Outcomes (1)

• The capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.

  Comparing various ultrasonographic signs of inflammation acquired by hand-held US machines to that acquired by high-end and premium US machines. Defining accuracy of hand-held ultrasound machines in the detection of bowel wall inflammatory activity

  fro enrollmeent to the end of the study at 2 years

Study Arms (1)

Crohn's patients undergoing routine intestinal ultrasound exam

Diagnostic Test: Intestinal ultrasound

Interventions

Intestinal ultrasound DIAGNOSTIC_TEST

Intestinal ultrasound performed by hand held ultrasound devices

Crohn's patients undergoing routine intestinal ultrasound exam

Eligibility Criteria

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

Study Population

The study population will include 150 consecutive Crohn's patients going through intestinal ultrasound at the discretion of their referring physician.

You may qualify if:

• Crohn disease of the terminal ileum and colon- Age\> 18

You may not qualify if:

• Pregnancy Inability to visualize he bowel on US Proximal Crohn's disease Proctitis

Sponsors & Collaborators

• Sheba Medical Center: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dan Carter, Associate Professor

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Carter, Associate professor

CONTACT

+97235302197; dan.carter@sheba.health.gov.il

Adi Talan

CONTACT

+972544615875; adi.talanasher@sheba.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, intestinal ultrasound service

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share