Implementation of Point Of Care UltraSound in the Assessment of Crohn's Disease -The POCUS Study

NCT ID: NCT07157436

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2021-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 skills/resources to deliver POCUS;
* can establish criteria for the service success of POCUS.
2. Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
3. Undertake care pathway analyses of POCUS and MRE service for IBD outpatients with small bowel CD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Explore Stakeholder perceptions of anticipated barriers and enablers to POCUS service development and implementation
2. Compare the impact of POCUS and MRE on the nature of decision-making of consultant gastroenterologists and their confidence in clinical decision making.
3. 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.

1. 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.
2. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease of Small Intestine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Non-interventional study

Intervention Type OTHER

observational study. non-interventional

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-interventional study

observational study. non-interventional

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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.

Exclusion Criteria

* Unable to communicate clearly in verbal and written English.
* Unable to access REDCap\* eCRF via NHS servers. \* https://projectredcap.org/software/
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nottingham NIHR Biomedical Research Centre

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21GA005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intraoperative Ultrasound in Crohn's Disease
NCT06388057 NOT_YET_RECRUITING NA
Ultrasound Evaluation of Crohn's Disease
NCT03235180 TERMINATED PHASE4