Crohn Disease (CD)NCT06686589
The Utility of Hand-held Ultrasound Devices to Detect Bowel Wall Inflammatory Activity in Crohn's Disease
An observational study of Crohn Disease (CD), run by Sheba Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Intestinal ultrasound
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 150 consecutive Crohn's patients going through intestinal ultrasound at the discretion of their referring physician.
Who may be able to join
- Crohn disease of the terminal ileum and colon- Age> 18
Who cannot join
- Pregnancy Inability to visualize he bowel on US Proximal Crohn's disease Proctitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
- 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
Read the detailed description
- Aim 1. Comparison of the accuracy of hand-held US machines for the detection and measurement of bowel wall inflammatory activity to that of advanced high-end and premium US machines by experienced IUS performers
- Rationale: IUS use has been incorporated into the processes of diagnosis, follow-up, monitoring, and treatment approaches in CD. One of the limiting factors of IUS dissemination relates to the high costs of the modern high-end and premium US machines used for intestinal ultrasound. Confirming the acceptable accuracy of affordable modern hand-held US machines for detection and measurement of inflammatory activity will enable dissemination of IUS use, as obtaining affordable and precise US machines will be possible.
- Overall Experimental Strategy and/or Methodology: 150 CD patients will undergo an IUS exam using a hand-held US machine (GE VSCAN air or Philips Lumify) followed by an exam using a high-end or premium US machine (GE S-8, BK 3000 and GE E-9). All exams will be performed by one of 3 experienced IUS performers (DC, AA, HB). The exams will be performed using the same consecutive method with a low-frequency curved array transducer enabling all abdominal quadrants to be examined for fill levels, potential pathological distension, motility, and para-intestinal structures such as abscesses, followed by examination using a high-resolution linear array for detailed examination of the bowel wall structure. All examinations will be performed without any preceding preparation, using a consistent technique and protocol, beginning the examination with the terminal ileum (TI), proximal to the distal colon, followed by an examination of the small bowel. The assessment will be performed for features of inflammation, especially bowel wall thickness of the TI and the colon. Bowel wall thickness will be measured at least in two different areas at a minimal distance of 1 cm from each other. Colonic bowel thickness will be measured at the right, transverse, left, and sigmoid colon. Small bowel wall thickness will be measured at the TI. The thickest measurement of each bowel segment will be chosen as a representative for measurement. Images and cine-loops of each segment of the colon and the TI will be saved on the tablet connected to the hand-held US machine.
Other signs of inflammation will also be examined: Doppler signs within the bowel wall using the modified Limberg scoring system, mesenteric fat hypertrophy, stratification of bowel wall layers and enlargement of lymph nodes.
Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas, and abscesses will be noted and the relative images will be saved.
The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines. A dichotomic comparison for the presence of each sign (yes/no) will be followed by a comparison of numerical parameters (exact bowel thickness measurement for each segment and Limberg score).
- The saved images and cine loops of each segment will be reviewed blindly by one of the other sonographers and assessed for inter-reader agreement between different performers.
- An ICC analysis will be performed for the primary outcome of bowel wall thickness.
- Expected Outcomes/Results: To define if the hand-held US machine can detect basic ultrasonographic signs of inflammation (bowel wall thickness) with adequate accuracy compared with gold-standard high-end \ premium US machines.
- Aim 2: Comparison of the accuracy of hand-held US machines for the detection and measurement of bowel wall inflammatory activity to that of advanced high-end and premium US machines by ultra-sonographers with ultra-sonographers with various experience levels.
- Rationale: Judging from preliminary experience, we hypothesize hand-held US machines will be accurate for the detection of inflammatory activity when used by experienced IUS performers. However, the accuracy of the hand-held ultrasound machine used by less experienced users will still need to be verified.
- Overall Experimental Strategy and/or Methodology:
Different levels of IUS experience will be defined based on the time from the conclusion of the IBUS curriculum and the number of IUS exams performed per month:
Novice- up to one year after the conclusion of the IBUS curriculum. Performs at least 20 exams per month.
Intermediate experience- 1-2 years after the conclusion of the IBUS curriculum. Performs at least 20 exams per month. Total exams performed 500-1000 Experienced- >2 years after the conclusion of the IBUS curriculum. Performed> 1000 exams.
- Hand-held ultrasound machines will be used by 10 ultra-sonographers with different levels of experience (3 novices, 4 intermediates, 3 experienced). The first 20 exams will be performed for reaching confidence using the US machine. Each ultra-sonographer will perform 50 exams using hand-held US machines and compare the results to the following exam performed by a high-end \ premium US machine (the same machines used for IUS in every sonographer's hospital). The assessment will be performed for features of inflammation, especially bowel wall thickness of the TI and the colon. Bowel wall thickness will be measured at least in two different areas at a minimal distance of 1 cm from each other. Colonic bowel thickness will be measured at the right colon, transverse colon, left colon and sigmoid colon. Small bowel thickness will be measured at the TI. The thickest segment of each bowel segment will be chosen for the purpose of measurement. Images and cine-loops of each segment of the colon and the TI will be saved on the tablet connected to the hand-held US machine. Other signs of inflammation will also be examined: Doppler signs within the bowel wall using the modified Limberg scoring system, fat hypertrophy, stratification of bowel wall layers and enlargement of lymph nodes. Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas and abscesses will be noted and the relative images will be saved. The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines. Dichotomic comparison for the presence of each sign (yes/no) will be followed by a comparison of numerical parameters when possible (exact bowel thickness measurement for each bowel segment and Limberg score). Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas and abscesses will be noted and the relative images will be saved. The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines.
- 20 percent of each performer's saved images and cine loops will be reviewed blindly by one of the 3 expert sonographers and assessed for the inter-reader agreement between performers.
- Conditions
- Crohn Disease (CD)
- Being tested
- Intestinal ultrasound
- Keywords
- Crohn disease, intestinal ultrasound, hand held ultrasound
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal ultrasoundDiagnostic test
Intestinal ultrasound performed by hand held ultrasound devices
| Study group | Role | What they receive |
|---|---|---|
| Crohn's patients undergoing routine intestinal ultrasound exam | Not described Receives: Diagnostic Test: Intestinal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: fro enrollmeent to the end of the study at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
- Investigators
- Dan Carter, Associate Professor, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686589
- Sponsor's protocol ID
- SHEBA-23-0523-DC-CTIL
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IUS images - the data for he study- can not be shared due to patient privecy issure
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Hand-held Ultrasound Devices to Detect Bowel Wall Inflammatory Activity in Crohn's Disease
- ClinicalTrials.gov ID
- NCT06686589
- Acronym / sponsor ID
- SHEBA-23-0523-DC-CTIL
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn disease, intestinal ultrasound, hand held ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Aim 1. Comparison of the accuracy of hand-held US machines for the detection and measurement of bowel wall inflammatory activity to that of advanced high-end and premium US machines by experienced IUS performers
- Rationale: IUS use has been incorporated into the processes of diagnosis, follow-up, monitoring, and treatment approaches in CD. One of the limiting factors of IUS dissemination relates to the high costs of the modern high-end and premium US machines used for intestinal ultrasound. Confirming the acceptable accuracy of affordable modern hand-held US machines for detection and measurement of inflammatory activity will enable dissemination of IUS use, as obtaining affordable and precise US machines will be possible.
- Overall Experimental Strategy and/or Methodology: 150 CD patients will undergo an IUS exam using a hand-held US machine (GE VSCAN air or Philips Lumify) followed by an exam using a high-end or premium US machine (GE S-8, BK 3000 and GE E-9). All exams will be performed by one of 3 experienced IUS performers (DC, AA, HB). The exams will be performed using the same consecutive method with a low-frequency curved array transducer enabling all abdominal quadrants to be examined for fill levels, potential pathological distension, motility, and para-intestinal structures such as abscesses, followed by examination using a high-resolution linear array for detailed examination of the bowel wall structure. All examinations will be performed without any preceding preparation, using a consistent technique and protocol, beginning the examination with the terminal ileum (TI), proximal to the distal colon, followed by an examination of the small bowel. The assessment will be performed for features of inflammation, especially bowel wall thickness of the TI and the colon. Bowel wall thickness will be measured at least in two different areas at a minimal distance of 1 cm from each other. Colonic bowel thickness will be measured at the right, transverse, left, and sigmoid colon. Small bowel wall thickness will be measured at the TI. The thickest measurement of each bowel segment will be chosen as a representative for measurement. Images and cine-loops of each segment of the colon and the TI will be saved on the tablet connected to the hand-held US machine.
Other signs of inflammation will also be examined: Doppler signs within the bowel wall using the modified Limberg scoring system, mesenteric fat hypertrophy, stratification of bowel wall layers and enlargement of lymph nodes.
Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas, and abscesses will be noted and the relative images will be saved.
The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines. A dichotomic comparison for the presence of each sign (yes/no) will be followed by a comparison of numerical parameters (exact bowel thickness measurement for each segment and Limberg score).
- The saved images and cine loops of each segment will be reviewed blindly by one of the other sonographers and assessed for inter-reader agreement between different performers.
- An ICC analysis will be performed for the primary outcome of bowel wall thickness.
- Expected Outcomes/Results: To define if the hand-held US machine can detect basic ultrasonographic signs of inflammation (bowel wall thickness) with adequate accuracy compared with gold-standard high-end \ premium US machines.
- Aim 2: Comparison of the accuracy of hand-held US machines for the detection and measurement of bowel wall inflammatory activity to that of advanced high-end and premium US machines by ultra-sonographers with ultra-sonographers with various experience levels.
- Rationale: Judging from preliminary experience, we hypothesize hand-held US machines will be accurate for the detection of inflammatory activity when used by experienced IUS performers. However, the accuracy of the hand-held ultrasound machine used by less experienced users will still need to be verified.
- Overall Experimental Strategy and/or Methodology:
Different levels of IUS experience will be defined based on the time from the conclusion of the IBUS curriculum and the number of IUS exams performed per month:
Novice- up to one year after the conclusion of the IBUS curriculum. Performs at least 20 exams per month.
Intermediate experience- 1-2 years after the conclusion of the IBUS curriculum. Performs at least 20 exams per month. Total exams performed 500-1000 Experienced- >2 years after the conclusion of the IBUS curriculum. Performed> 1000 exams.
- Hand-held ultrasound machines will be used by 10 ultra-sonographers with different levels of experience (3 novices, 4 intermediates, 3 experienced). The first 20 exams will be performed for reaching confidence using the US machine. Each ultra-sonographer will perform 50 exams using hand-held US machines and compare the results to the following exam performed by a high-end \ premium US machine (the same machines used for IUS in every sonographer's hospital). The assessment will be performed for features of inflammation, especially bowel wall thickness of the TI and the colon. Bowel wall thickness will be measured at least in two different areas at a minimal distance of 1 cm from each other. Colonic bowel thickness will be measured at the right colon, transverse colon, left colon and sigmoid colon. Small bowel thickness will be measured at the TI. The thickest segment of each bowel segment will be chosen for the purpose of measurement. Images and cine-loops of each segment of the colon and the TI will be saved on the tablet connected to the hand-held US machine. Other signs of inflammation will also be examined: Doppler signs within the bowel wall using the modified Limberg scoring system, fat hypertrophy, stratification of bowel wall layers and enlargement of lymph nodes. Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas and abscesses will be noted and the relative images will be saved. The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines. Dichotomic comparison for the presence of each sign (yes/no) will be followed by a comparison of numerical parameters when possible (exact bowel thickness measurement for each bowel segment and Limberg score). Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas and abscesses will be noted and the relative images will be saved. The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines.
- 20 percent of each performer's saved images and cine loops will be reviewed blindly by one of the 3 expert sonographers and assessed for the inter-reader agreement between performers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's patients undergoing routine intestinal ultrasound exam | – | Diagnostic Test: Intestinal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 150 consecutive Crohn's patients going through intestinal ultrasound at the discretion of their referring physician.
Key inclusion criteria (1 listed)
- Crohn disease of the terminal ileum and colon- Age> 18
Key exclusion criteria (1 listed)
- Pregnancy Inability to visualize he bowel on US Proximal Crohn's disease Proctitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal ultrasoundIntestinal ultrasound performed by hand held ultrasound devices | Diagnostic test | Crohn's patients undergoing routine intestinal ultrasound exam |
Primary outcome
The capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.
Time frame: fro enrollmeent to the end of the study at 2 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No. IUS images - the data for he study- can not be shared due to patient privecy issure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Carter, Associate Professor principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD), run by Sheba Medical Center.
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 1 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: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Carter, Associate professor (+97235302197, dan.carter@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients. (time frame: fro enrollmeent to the end of the study at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2024.