Crohn Disease of Small IntestinePOCUSNCT07157436
Implementation of Point Of Care UltraSound in the Assessment of Crohn's Disease -The POCUS Study
An observational study of Crohn Disease of Small Intestine, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
1. Explore Stakeholder perceptions of POCUS service development and implementation in the NHS in an interview Sub-study. We will assess whether stakeholders: Recognise the potential of POCUS for the management of small bowel CD; feel that it should be integrated into local services; feel that they have the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease of Small Intestine
- What is being tested?
- Non-interventional study
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2021to 1 Oct 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One of the following roles * NHS Gastroenterology consultant * NHS IBD Nurse Specialist * NHS Consultant Radiologist * NHS business managers working in gastrointestinal services * Patient under the care of the NHS for small bowel CD.
Who may be able to join
- Able to give valid informed consent
- Aged 18 years or over.
- One of the following roles
- NHS Gastroenterology consultant
- NHS IBD Nurse Specialist
- NHS Consultant Radiologist
Show all 15Show fewer
- NHS business managers working in gastrointestinal services
- Patient under the care of the NHS for small bowel CD. Exclusion criteria
- Unable to communicate clearly in verbal and written English.
- Clinical Decision-making study Inclusion criteria
- Ability to give informed consent.
- Full time NHS Consultant Gastroenterologist (on GMC specialist register).
- Agreement to comply with the study training requirements, protocol and regulatory/ sponsor stipulations.
- Have access to local Point Of Care UltraSound (POCUS) and Magnetic Resonance Enterography (MRE) services Exclusion criteria
- Unable to access REDCap* eCRF via NHS servers. * https://projectredcap.org/software/
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham NIHR Biomedical Research Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Implementation of Point Of Care UltraSound in the Assessment of Crohn's Disease
- Explore Stakeholder perceptions of POCUS service development and implementation in the NHS in an interview Sub-study. We will assess whether stakeholders:
- Recognise the potential of POCUS for the management of small bowel CD;
- feel that it should be integrated into local services;
- feel that they have the skills/resources to deliver POCUS;
- can establish criteria for the service success of POCUS.
- Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
- Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.
Read the detailed description
To demonstrate feasibility of implementing POCUS for the diagnosis and management of small bowel CD in adult ambulatory IBD care and identify the barriers for wide-spread NHS adoption
Objectives:
- Explore Stakeholder perceptions of anticipated barriers and enablers to POCUS service development and implementation
- Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
- Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.
Outcome:
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.
- Qualitative interview study: Inclusion criteria
- Able to give valid informed consent
- Aged 18 years or over.
- One of the following roles
- NHS Gastroenterology consultant
- NHS IBD Nurse Specialist
- NHS Consultant Radiologist
- NHS business managers working in gastrointestinal services
- Patient under the care of the NHS for small bowel CD. Exclusion criteria
- Unable to communicate clearly in verbal and written English.
- Clinical Decision-making study Inclusion criteria
- Ability to give informed consent.
- Full time NHS Consultant Gastroenterologist (on GMC specialist register).
- Agreement to comply with the study training requirements, protocol and regulatory/ sponsor stipulations.
- Have access to local Point Of Care UltraSound (POCUS) and Magnetic Resonance Enterography (MRE) services Exclusion criteria
- Unable to access REDCap* eCRF via NHS servers. * https://projectredcap.org/software/
- Conditions
- Crohn Disease of Small Intestine
- Being tested
- Non-interventional study
- Keywords
- Ultrasound, Service Improvement
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
observational study. non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Qualitative interview study | • One of the following roles:
* NHS Gastroenterology consultant
* NHS IBD Nurse Specialist
* NHS Consultant Radiologist
* NHS business managers working in gastrointestinal services
* Patient under the care of the NHS for small bowel CD. Receives: Other: Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.
Total project outcome
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start26 May 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: Lack of Recruitment due to COVID-19 Pandemic (no face to face patient appointments)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease of Small IntestineStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157436
- Sponsor's protocol ID
- 21GA005
- Acronym
- POCUS
- Status last verified
- Jun 2021
- First submitted
- 21 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Point Of Care UltraSound in the Assessment of Crohn's Disease
- ClinicalTrials.gov ID
- NCT07157436
- Acronym / sponsor ID
- POCUS / 21GA005
- Conditions
- Crohn Disease of Small Intestine
- Keywords
- Ultrasound, Service Improvement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of Recruitment due to COVID-19 Pandemic (no face to face patient appointments)
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Sep 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.
- Explore Stakeholder perceptions of POCUS service development and implementation in the NHS in an interview Sub-study. We will assess whether stakeholders:
- Recognise the potential of POCUS for the management of small bowel CD;
- feel that it should be integrated into local services;
- feel that they have the skills/resources to deliver POCUS;
- can establish criteria for the service success of POCUS.
- Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
- Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.
Detailed description
To demonstrate feasibility of implementing POCUS for the diagnosis and management of small bowel CD in adult ambulatory IBD care and identify the barriers for wide-spread NHS adoption
Objectives:
- Explore Stakeholder perceptions of anticipated barriers and enablers to POCUS service development and implementation
- Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
- Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.
Outcome:
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.
- Qualitative interview study: Inclusion criteria
- Able to give valid informed consent
- Aged 18 years or over.
- One of the following roles
- NHS Gastroenterology consultant
- NHS IBD Nurse Specialist
- NHS Consultant Radiologist
- NHS business managers working in gastrointestinal services
- Patient under the care of the NHS for small bowel CD. Exclusion criteria
- Unable to communicate clearly in verbal and written English.
- Clinical Decision-making study Inclusion criteria
- Ability to give informed consent.
- Full time NHS Consultant Gastroenterologist (on GMC specialist register).
- Agreement to comply with the study training requirements, protocol and regulatory/ sponsor stipulations.
- Have access to local Point Of Care UltraSound (POCUS) and Magnetic Resonance Enterography (MRE) services Exclusion criteria
- Unable to access REDCap* eCRF via NHS servers. * https://projectredcap.org/software/
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative interview study | – | Other: Non-interventional study• One of the following roles: * NHS Gastroenterology consultant * NHS IBD Nurse Specialist * NHS Consultant Radiologist * NHS business managers working in gastrointestinal services * Patient under the care of the NHS for small bowel CD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One of the following roles * NHS Gastroenterology consultant * NHS IBD Nurse Specialist * NHS Consultant Radiologist * NHS business managers working in gastrointestinal services * Patient under the care of the NHS for small bowel CD.
Key inclusion criteria (15 listed)
- Clinical Decision-making study Inclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Non-interventional studyobservational study. non-interventional | Other | Qualitative interview study |
Primary outcome
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.
Time frame: 36 months
Total project outcome
Results and safety
The study was stopped early (reason given: Lack of Recruitment due to COVID-19 Pandemic (no face to face patient appointments)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease of Small Intestine
Active, not recruitingObservational study
Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis
Irritable Bowel Syndrome, Crohn Disease
Recruiting
Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease
Crohn Disease (CD), Intestinal Stricture
Recruiting
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Crohn's Disease
Active, not recruiting
Small Bowel Deep Learning Algorithm Project
Crohn Disease
RecruitingObservational study
Development of New Diagnostic Tools in Capsule Endoscopy
Bowel Disease, Crohn 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease of Small Intestine, run by Nottingham University Hospitals NHS Trust 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 5 Sep 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 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 was stopped early (reason given: Lack of Recruitment due to COVID-19 Pandemic (no face to face patient appointments)). Results are not available in the source record.
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?
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice. (time frame: 36 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 5 Sep 2025.