Inflammatory Bowel DiseasesNCT05838196
Service Development of POCUS in the IBD Clinic
A study testing Point-of-care ultrasound in people with Inflammatory Bowel Diseases, run by University College, London at 1 site in United Kingdom.
Trial summary
Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Point-of-care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 years or above
- Attending IBD clinic face-to-face
- Able to give informed consent.
- Belonging to one of the following groups:
- New patients with high clinical suspicion of IBD
- Known UC/IBD-U and possible flare
Show all 9Show fewer
- Known Crohn's and possible flare
- Known IBD and assessing response to a new medication or following surgery
- Known IBD and clinician planning endoscopic or radiological investigations
Who cannot join
- Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals NHS Trust
London, NW1 2PG
About this study
Official title: Does the Use of Point of Care Ultrasound During Inflammatory Bowel Disease Clinic Appointments Change Management, Speed up Treatment Decisions and Save Money: a Feasibility and Service Development Study
Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.
Read the detailed description
After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Point-of-care ultrasound
- Keywords
- Intestinal ultrasound
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDiagnostic test
Point-of-care ultrasound performed during clinic appointment
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participant will follow standard of care |
| Point-of-care Ultrasound | Experimental | Participant will receive point-of-care ultrasound at time of clinic appointment and clinician will use result to inform treatment decision Receives: Diagnostic Test: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care
Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment
Measured: 6 months
Secondary outcomes (9)
Does point of care ultrasound change clinical decision making in the IBD clinic
Does the clinical decision made before ultrasound differ from that following ultrasound.
Measured: Immediate
Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)
Using formalised imaging or endoscopy as gold standard for determining disease activity, compare findings on POCUS to determine sensitivity and specificity
Measured: 6 months
Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care
Using NHS cost tariffs, estimated costs for participants following standard of care to those receiving POCUS over the year following enrolment
Measured: 1 year
Compare findings at POCUS when performed by a gastroenterologist or a radiologist
POCUS will be performed by gastroenterologists or radiologist and outcomes on sensitivity/specificity will be compared between the two
Measured: 6 months
Compare clinical disease activity scores when POCUS is used compared with standard of care
Using disease activity score questionnaires (HBI (If Crohn's disease) or SCCAI (If ulcerative Colitis)) at baseline and six months.
Measured: 6 months
Compare use of steroids with POCUS compared with standard of care
Number of courses of steroids and total steroid dose over the duration of the trial
Measured: 1 year
Compare haemaglobin levels when POCUS is used compared with standard of care
Are there significant difference between the change in haemaglobin from baseline to six months in the POCUS group compared with standard of care
Measured: 6 months
Compare CRP levels when POCUS is used compared with standard of care
Are there significant difference between the change in CRP from baseline to six months in the POCUS group compared with standard of care
Measured: 6 months
Compare Platelets when POCUS is used compared with standard of care
Are there significant difference between the change in platelets from baseline to six months in the POCUS group compared with standard of care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start24 Apr 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Blad, BM BCh, Principal investigator, University College London Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838196
- Sponsor's protocol ID
- 155436
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Point of Care Ultrasound During Inflammatory Bowel Disease Clinic Appointments Change Management, Speed up Treatment Decisions and Save Money: a Feasibility and Service Development Study
- ClinicalTrials.gov ID
- NCT05838196
- Acronym / sponsor ID
- 155436
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Intestinal ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 1 May 2023 (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.
Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.
Detailed description
After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participant will follow standard of care |
| Point-of-care Ultrasound | Experimental | Diagnostic Test: Point-of-care ultrasoundParticipant will receive point-of-care ultrasound at time of clinic appointment and clinician will use result to inform treatment decision |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age 16 years or above
- Attending IBD clinic face-to-face
- Able to give informed consent.
- Belonging to one of the following groups:
Key exclusion criteria (1 listed)
- Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension
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 |
|---|---|---|
| Point-of-care ultrasoundPoint-of-care ultrasound performed during clinic appointment | Diagnostic test | Point-of-care Ultrasound |
Primary outcome
Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care
Time frame: 6 months
Time in days for when a new medication is started, dose changed, medication stopped, or surgery performed following the clinic appointment
9 secondary outcomes
Does point of care ultrasound change clinical decision making in the IBD clinic
Time frame: Immediate
Compare sensitivity and specificity of POCUS to identify active disease with standard of care investigations (MRI, ultrasound, endoscopy)
Time frame: 6 months
Compare healthcare resource utilisation including outpatient appointments, need for further investigations and admissions in patients receiving POCUS or standard of care
Time frame: 1 year
Compare findings at POCUS when performed by a gastroenterologist or a radiologist
Time frame: 6 months
Compare clinical disease activity scores when POCUS is used compared with standard of care
Time frame: 6 months
Compare use of steroids with POCUS compared with standard of care
Time frame: 1 year
Compare haemaglobin levels when POCUS is used compared with standard of care
Time frame: 6 months
Compare CRP levels when POCUS is used compared with standard of care
Time frame: 6 months
Compare Platelets when POCUS is used compared with standard of care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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. This study is not recruiting at the moment.
William Blad, BM BCh principal investigator
University College London Hospitals Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound in people with Inflammatory Bowel Diseases, run by University College, London at 1 site in United Kingdom.
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 9 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: finished, as of the sponsor's last update on 16 Dec 2024. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare time to definitive IBD-related treatment initiation with the use of POCUS compared to standard of care (time frame: 6 months). 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 16 Dec 2024.