Implementation of Point Of Care UltraSound in the Assessm... | NCT07157436

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

NCT07157436

Sponsor

Nottingham University Hospitals NHS Trust

Status

Terminated

Last Update Posted

Sep 5, 2025Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Crohn Disease of Small Intestine

Interventions

Non-interventional study

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of Recruitment due to COVID-19 Pandemic (no face to face patient appointments)

Expanded Access Info

Start Date

May 26, 2021Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Aug 21, 2025

First Submission Date that Met QC Criteria

Aug 28, 2025

First Posted Date

Sep 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2025

Last Update Posted Date

Sep 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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/

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: Non-interventional study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-interventional study	Other	observational study. non-interventional	Qualitative interview study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To create an implementation toolkit to facilitate widespread POCUS adoption and integration within NHS IBD clinical practice.	Total project outcome	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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/

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham NIHR Biomedical Research Centre		Nottingham	Nottinghamshire	NG7 2UH	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases