Inflammatory Bowel Disease (IBD)HUMIDNCT06938295
Comparing Diagnostic Accuracy of High-end Intestinal Ultrasound Versus Mid-end Ultrasound With Tandem Ileo-colonoscopy in Inflammatory Bowel Disease : a Paired, Validating Confirmatory Study
A study testing Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment in people with Inflammatory Bowel Disease (IBD), run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
The HUMID Study (High-end vs. Mid-end Ultrasound in IBD Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study evaluating the performance of mid-end versus high-end intestinal ultrasound (IUS) machines in assessing ileocolonic involvement in patients with inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 14 Sep 2024to 30 Oct 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years.
- Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
- Clinically stable at the time of assessment.
- Willing and able to undergo both intestinal ultrasound (IUS) assessments (mid-end and high-end) and the reference standard ileo-colonoscopy.
- Provides informed consent to participate in the study.
Who cannot join
- Pregnant or breastfeeding individuals.
- Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
- Individuals unable to provide informed consent.
- Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Duvvuru Nageshwar Reddy, MD, DM, MASGE, FACG, AGAF, +91-40-23378888, aigindia@yahoo.co.in
Partha Pal, MD, DNB, MRCP(UK), FASGE
About this study
Official title: Comparing Diagnostic Accuracy of High-End Intestinal Ultrasound Versus Mid-End Ultrasound With Tandem Ileo-Colonoscopy in Inflammatory Bowel Disease (The HUMID Study): A Paired, Validating Confirmatory Study
The HUMID Study (High-end vs. Mid-end Ultrasound in IBD Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study evaluating the performance of mid-end versus high-end intestinal ultrasound (IUS) machines in assessing ileocolonic involvement in patients with inflammatory bowel disease (IBD). Conducted at the Asian Institute of Gastroenterology, this study compares the Siemens ACUSON S2000 (mid-end) with the Samsung RS85 (high-end) ultrasound machines, using ileo-colonoscopy as the reference standard. All enrolled patients will undergo clinical evaluation, IUS with both machines, and colonoscopy. The primary objective is to assess and compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the two ultrasound systems. Secondary objectives include evaluating the impact of IUS findings on clinical management. The study aims to provide evidence for cost-effective imaging strategies in resource-limited settings where access to advanced diagnostics is restricted.
Read the detailed description
The HUMID Study (High-end versus Mid-end Ultrasound in Inflammatory Bowel Disease Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study designed to compare the performance of two intestinal ultrasound systems-a high-end system (Samsung RS85) and a mid-end system (Siemens ACUSON S2000)-in detecting ileocolonic inflammation in patients with inflammatory bowel disease. The study uses ileo-colonoscopy as the diagnostic reference standard and also evaluates the impact of ultrasound findings on clinical management and potential cost savings in resource-limited settings.
Eligible patients with known inflammatory bowel disease involving the colon and/or terminal ileum will undergo two intestinal ultrasound examinations followed by ileo-colonoscopy. To minimize operator bias, the mid-end ultrasound examination will be performed and interpreted by an experienced gastrointestinal sonologist using the Siemens ACUSON S2000 system. The high-end ultrasound examination will be conducted independently by an inflammatory bowel disease specialist using the Samsung RS85 system. Both sonographers will be blinded to each other's findings and to colonoscopy results. The examinations will be conducted in close succession on the same day, using standardized scanning protocols and probe frequencies suitable for bowel wall assessment.
Ultrasound assessments will include bowel wall thickness, mural stratification, vascularity, and disease extent. All findings will be recorded on pre-specified case report forms. Ileo-colonoscopy will be performed within 24 hours of the ultrasound exams by a separate blinded endoscopist. Endoscopic activity scores will be used as the reference standard for determining diagnostic accuracy.
The primary objective is to compare the diagnostic accuracy-measured by sensitivity, specificity, positive predictive value, and negative predictive value-of mid-end versus high-end ultrasound systems in detecting ileocolonic disease activity. The study aims to determine whether mid-end machines, which are more affordable and accessible, can offer comparable diagnostic performance to high-end systems.
Secondary objectives include assessing whether ultrasound findings lead to changes in clinical management. To ensure objectivity, an independent panel of three experienced inflammatory bowel disease physicians-blinded to the identity of the ultrasound machine-will review each case and determine whether ultrasound findings would have justified changes such as treatment escalation or de-escalation, surgical referral, or additional diagnostic evaluation. Panel decisions will be based on standardized clinical scenarios and will be adjudicated by consensus.
The study also includes a health-economic component, analyzing how the integration of mid-end ultrasound into clinical workflows may reduce reliance on invasive and high-cost diagnostics like colonoscopy or cross-sectional imaging. Real-world cost estimates will be used to model the economic impact.
By providing comparative data on diagnostic accuracy, management impact, and economic value, the HUMID Study seeks to inform clinical practice guidelines and promote the use of scalable ultrasound solutions in inflammatory bowel disease, particularly in resource-constrained healthcare settings.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment
- Keywords
- Ultrasound, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessmentDiagnostic test
This study compares two intestinal ultrasound (IUS) devices-a high-end machine (Samsung RS85) and a mid-end machine (Siemens ACUSON S2000)-for assessing ileocolonic inflammation in IBD patients. The high-end device offers advanced imaging features, including high-resolution, speckle reduction, and extended field of view, allowing for detailed visualization of the bowel wall and vascularity. The mid-end device, while more basic, provides essential IUS functions for examining bowel wall thickness, structure, and inflammation markers. Both devices are used in a single clinical session, with results compared against tandem ileo-colonoscopy as the reference standard. This unique dual approach enables evaluation of the diagnostic performance of each device type. If comparable, the mid-end device may offer a cost-effective solution, increasing access to routine IUS in various healthcare settings, especially where high-end technology is limited.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with inflammatory bowel disease | Active comparator | Participants will undergo intestinal ultrasound (IUS) assessments using both a high-end (Samsung RS85) and a mid-end (Siemens ACUSON S2000) ultrasound machine to evaluate ileocolonic inflammation in inflammatory bowel disease (IBD). Each device is used within the same session, focusing on bowel wall thickness, vascularity, and structural changes. The high-end ultrasound provides advanced imaging capabilities, while the mid-end device offers standard IUS functionalities. Tandem ileo-colonoscopy is performed as the reference standard to validate findings.
Primary Outcome: Diagnostic accuracy (sensitivity, specificity) of high-end vs. mid-end ultrasound.
Secondary Outcome: Impact of ultrasound findings on clinical management decisions, evaluating cost-effective options for routine IBD monitoring. Receives: Diagnostic Test: Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-Colonoscopy
Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of mid-end ultrasound (Siemens ACUSON S2000) and high-end ultrasound (Samsung RS85) in detecting inflammation in the terminal ileum and colon, as compared to findings on ileo-colonoscopy (reference standard). Each patient will undergo both ultrasound examinations followed by ileo-colonoscopy. Sonographic features assessed include bowel wall thickness, mural stratification, and vascularity. Colonoscopy will be scored using validated endoscopic indices such as the Simple Endoscopic Score for Crohn's Disease and the Ulcerative Colitis Endoscopic Index of Severity.
Measured: Day 1 (same day as colonoscopy)
Secondary outcomes (1)
Number of Participants With Change in Clinical Management Based on Ultrasound Findings as Determined by Independent Physician Panel
Number of participants in whom treatment decisions (e.g., escalation or de-escalation of medical therapy, surgical referral, or ordering of additional diagnostic testing) were modified based on findings from mid-end or high-end ultrasound. An independent, blinded panel of three inflammatory bowel disease specialists will review clinical scenarios with and without ultrasound results and adjudicate whether ultrasound findings contributed to a management change.
Measured: Within 24 hours of ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start14 Sep 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938295
- Sponsor's protocol ID
- AIG/IEC-BH&R 61/09.2024-01
- Acronym
- HUMID
- Status last verified
- Jul 2025
- First submitted
- 21 Nov 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pal P, Mateen MA, Naaz SM, Pooja K, Nittala R, Singh A, Reddy BK, Reddy Vasepally PK, Najbuddin SM, Maharshi TS, Marri UK, Nabi Z, Reddy PM, Basha J, Gupta R, Tandan M, Talukdar R, Reddy DN. High-end intestinal ultrasound versus mid-end systems benchmarked against tandem ileocolonoscopy in inflammatory bowel disease (HUMID): a paired prospective, validating confirmatory study. EClinicalMedicine. 2026 Apr 1;94:103856. doi: 10.1016/j.eclinm.2026.103856. eCollection 2026 Apr.
PubMed 41969335
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Diagnostic Accuracy of High-End Intestinal Ultrasound Versus Mid-End Ultrasound With Tandem Ileo-Colonoscopy in Inflammatory Bowel Disease (The HUMID Study): A Paired, Validating Confirmatory Study
- ClinicalTrials.gov ID
- NCT06938295
- Acronym / sponsor ID
- HUMID / AIG/IEC-BH&R 61/09.2024-01
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- Ultrasound, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 22 Apr 2025 (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.
The HUMID Study (High-end vs. Mid-end Ultrasound in IBD Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study evaluating the performance of mid-end versus high-end intestinal ultrasound (IUS) machines in assessing ileocolonic involvement in patients with inflammatory bowel disease (IBD). Conducted at the Asian Institute of Gastroenterology, this study compares the Siemens ACUSON S2000 (mid-end) with the Samsung RS85 (high-end) ultrasound machines, using ileo-colonoscopy as the reference standard. All enrolled patients will undergo clinical evaluation, IUS with both machines, and colonoscopy. The primary objective is to assess and compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of the two ultrasound systems. Secondary objectives include evaluating the impact of IUS findings on clinical management. The study aims to provide evidence for cost-effective imaging strategies in resource-limited settings where access to advanced diagnostics is restricted.
Detailed description
The HUMID Study (High-end versus Mid-end Ultrasound in Inflammatory Bowel Disease Diagnostics) is a prospective, cross-sectional, paired diagnostic accuracy study designed to compare the performance of two intestinal ultrasound systems-a high-end system (Samsung RS85) and a mid-end system (Siemens ACUSON S2000)-in detecting ileocolonic inflammation in patients with inflammatory bowel disease. The study uses ileo-colonoscopy as the diagnostic reference standard and also evaluates the impact of ultrasound findings on clinical management and potential cost savings in resource-limited settings.
Eligible patients with known inflammatory bowel disease involving the colon and/or terminal ileum will undergo two intestinal ultrasound examinations followed by ileo-colonoscopy. To minimize operator bias, the mid-end ultrasound examination will be performed and interpreted by an experienced gastrointestinal sonologist using the Siemens ACUSON S2000 system. The high-end ultrasound examination will be conducted independently by an inflammatory bowel disease specialist using the Samsung RS85 system. Both sonographers will be blinded to each other's findings and to colonoscopy results. The examinations will be conducted in close succession on the same day, using standardized scanning protocols and probe frequencies suitable for bowel wall assessment.
Ultrasound assessments will include bowel wall thickness, mural stratification, vascularity, and disease extent. All findings will be recorded on pre-specified case report forms. Ileo-colonoscopy will be performed within 24 hours of the ultrasound exams by a separate blinded endoscopist. Endoscopic activity scores will be used as the reference standard for determining diagnostic accuracy.
The primary objective is to compare the diagnostic accuracy-measured by sensitivity, specificity, positive predictive value, and negative predictive value-of mid-end versus high-end ultrasound systems in detecting ileocolonic disease activity. The study aims to determine whether mid-end machines, which are more affordable and accessible, can offer comparable diagnostic performance to high-end systems.
Secondary objectives include assessing whether ultrasound findings lead to changes in clinical management. To ensure objectivity, an independent panel of three experienced inflammatory bowel disease physicians-blinded to the identity of the ultrasound machine-will review each case and determine whether ultrasound findings would have justified changes such as treatment escalation or de-escalation, surgical referral, or additional diagnostic evaluation. Panel decisions will be based on standardized clinical scenarios and will be adjudicated by consensus.
The study also includes a health-economic component, analyzing how the integration of mid-end ultrasound into clinical workflows may reduce reliance on invasive and high-cost diagnostics like colonoscopy or cross-sectional imaging. Real-world cost estimates will be used to model the economic impact.
By providing comparative data on diagnostic accuracy, management impact, and economic value, the HUMID Study seeks to inform clinical practice guidelines and promote the use of scalable ultrasound solutions in inflammatory bowel disease, particularly in resource-constrained healthcare settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with inflammatory bowel disease | Active comparator | Diagnostic Test: Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessmentParticipants will undergo intestinal ultrasound (IUS) assessments using both a high-end (Samsung RS85) and a mid-end (Siemens ACUSON S2000) ultrasound machine to evaluate ileocolonic inflammation in inflammatory bowel disease (IBD). Each device is used within the same session, focusing on bowel wall thickness, vascularity, and structural changes. The high-end ultrasound provides advanced imaging capabilities, while the mid-end device offers standard IUS functionalities. Tandem ileo-colonoscopy is performed as the reference standard to validate findings. Primary Outcome: Diagnostic accuracy (sensitivity, specificity) of high-end vs. mid-end ultrasound. Secondary Outcome: Impact of ultrasound findings on clinical management decisions, evaluating cost-effective options for routine IBD monitoring. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-75 years.
- Confirmed diagnosis of inflammatory bowel disease (IBD), specifically with ileocolonic involvement.
- Clinically stable at the time of assessment.
- Willing and able to undergo both intestinal ultrasound (IUS) assessments (mid-end and high-end) and the reference standard ileo-colonoscopy.
- Provides informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding individuals.
- Patients with contraindications to ileo-colonoscopy (e.g., severe comorbidities, known intolerance).
- Individuals unable to provide informed consent.
- Patients with conditions interfering with ultrasound imaging, such as severe obesity or uncooperative behaviour
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 |
|---|---|---|
| Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessmentThis study compares two intestinal ultrasound (IUS) devices-a high-end machine (Samsung RS85) and a mid-end machine (Siemens ACUSON S2000)-for assessing ileocolonic inflammation in IBD patients. The high-end device offers advanced imaging features, including high-resolution, speckle reduction, and extended field of view, allowing for detailed visualization of the bowel wall and vascularity. The mid-end device, while more basic, provides essential IUS functions for examining bowel wall thickness, structure, and inflammation markers. Both devices are used in a single clinical session, with results compared against tandem ileo-colonoscopy as the reference standard. This unique dual approach enables evaluation of the diagnostic performance of each device type. If comparable, the mid-end device may offer a cost-effective solution, increasing access to routine IUS in various healthcare settings, especially where high-end technology is limited. | Diagnostic test | Adult patients with inflammatory bowel disease |
Primary outcome
Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-Colonoscopy
Time frame: Day 1 (same day as colonoscopy)
Diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of mid-end ultrasound (Siemens ACUSON S2000) and high-end ultrasound (Samsung RS85) in detecting inflammation in the terminal ileum and colon, as compared to findings on ileo-colonoscopy (reference standard). Each patient will undergo both ultrasound examinations followed by ileo-colonoscopy. Sonographic features assessed include bowel wall thickness, mural stratification, and vascularity. Colonoscopy will be scored using validated endoscopic indices such as the Simple Endoscopic Score for Crohn's Disease and the Ulcerative Colitis Endoscopic Index of Severity.
1 secondary outcome
Number of Participants With Change in Clinical Management Based on Ultrasound Findings as Determined by Independent Physician Panel
Time frame: Within 24 hours of ultrasound examination
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 16 Jul 2025.
- Derived from this study: PubMed 41969335Pal P, Mateen MA, Naaz SM, Pooja K, Nittala R, Singh A, Reddy BK, Reddy Vasepally PK, Najbuddin SM, Maharshi TS, Marri UK, Nabi Z, Reddy PM, Basha J, Gupta R, Tandan M, Talukdar R, Reddy DN. High-end intestinal ultrasound versus mid-end systems benchmarked against tandem ileocolonoscopy in inflammatory bowel disease (HUMID): a paired prospective, validating confirmatory study. EClinicalMedicine. 2026 Apr 1;94:103856. doi: 10.1016/j.eclinm.2026.103856. eCollection 2026 Apr.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparative Use of High-End and Mid-End Intestinal Ultrasound Devices for IBD Disease activity assessment in people with Inflammatory Bowel Disease (IBD), run by Asian Institute of Gastroenterology, India at 1 site in India.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Jul 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 India. 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?
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 Partha Pal, MD, DNB, MRCP (UK), FASGE (+91-8945906823, partha0123456789@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Mid-End and High-End Ultrasound in Detecting Ileocolonic Inflammation Compared to Ileo-Colonoscopy (time frame: Day 1 (same day as colonoscopy)). 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 NCT06938295, which also lists 1 linked publication.
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 16 Jul 2025.