Emergency MedicineAbdoPOCUSNCT07849569
Point-of-Care Ultrasound for Diagnosing Abdominal Pain in the Emergency Department
A study testing Point of care ultrasound in people with Emergency Medicine and POCUS, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The goal of this clinical trial is to learn if adding an abdominal ultrasound scan to the standard examination helps emergency physicians make a correct diagnosis in adults with acute abdominal pain in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, POCUS, Abdominal Pain (AP)
- What is being tested?
- Point of care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Oct 2026to Aug 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ED contact.
- Age ≥18 years.
- Non-traumatic, acute abdominal pain, defined as symptom onset ≤7 days prior to presentation, as chief complaint.
- Ability to provide written informed consent, as judged by the enrolling physician, and to communicate in Danish or English.
Who cannot join
- Prior enrollment in the trial.
- Patients in whom the cause of the current abdominal pain is considered known at the time of enrolment (previously diagnosed condition explaining the current symptoms, e.g. known symptomatic gallstone disease).
- Prior physician assessment of the presenting abdominal complaint during the current ED visit.
- Prior ED assessment or received an abdominal ultrasound or CT scan for the same complaint, within the preceding 7 days.
- Chronic abdominal pain, defined as abdominal pain persisting or recurring for ≥3 months(17), where the current episode represents an exacerbation of the chronic condition.
- Patients requiring immediate critical care or rapid-response team activation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Esbjerg Akutafdeling
Esbjerg, 8700
Peter B Biesenback, MD., PhD., +45 79185805, Peter.Biesenbach@rsyd.dk
Horsens Akutafdeling
Horsens, 8700
Jesper B Weile, MD., PhD., jesper.weile@clin.au.dk
Køge Akutafdeling
Køge
Danny Yu, MD, dy@regionsjaelland.dk
About this study
Official title: Effect of Abdominal Point-of-care Ultrasound on Correct Preliminary Diagnosis in Adult Emergency Department Patients With Acute Abdominal Pain: Protocol for a Multicentre, Parallel-group, Randomized Superiority Trial
The goal of this clinical trial is to learn if adding an abdominal ultrasound scan to the standard examination helps emergency physicians make a correct diagnosis in adults with acute abdominal pain in the emergency department. The main question it aims to answer is:
Does adding an abdominal point of care ultrasound scan to the standard examination increase the number of patients with acute abdominal pain in the emergency department, who get a correct preliminary diagnosis?
Read more
Researchers will compare patients examined with an abdominal point-of-care ultrasound scan in addition to the standard examination to patients examined with the standard examination alone, to see if adding ultrasound improves diagnostic accuracy.
Participants will:
- Be randomly assigned to also have an abdominal point-of-care ultrasound scan performed by their doctor, or not
- Have their doctor record a preliminary diagnosis and differential diagnosis
- Have their medical records reviewed by an independent panel 30 days after their visit, to determine their final diagnosis
- Conditions
- Emergency Medicine, POCUS, Abdominal Pain (AP), Acute Abdominal Pain, Ultrasound
- Being tested
- Point of care ultrasound
- Keywords
- Point of care ultrasound, Emergency department, Emergency physician, Abdominal pain, Acute abdominal pain, Ultrasound, Bedside ultrasound, Emergency medicine, Randomized controlled trial, Multicenter trial, Diagnostic efficacy
- Medical subject headings
- Abdominal Pain, Abdomen, Acute, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDiagnostic test
The abdominal point-of-care ultrasound examination is performed by the enrolling emergency physician at the bedside, as part of the initial assessment, rather than by a radiologist or sonographer.
The examination follows a standardized scanning protocol developed by the study steering committee, covering conditions that are common or critical in the emergency department, accessible to point-of-care ultrasound, and supported by evidence on diagnostic accuracy. The examination typically takes 5 to 10 minutes. Findings may guide further diagnostics or treatment at the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Standard examination + Abdominal point-of-care ultrasound group (Intervention) | Experimental | Participants in the intervention group will undergo an abdominal point-of-care ultrasound examination in addition to the standard clinical examination. The scan will be performed by the enrolling physician as part of the initial bedside assessment, with timing, workflow, equipment, transducer, and preset left to the physician's discretion. The examination typically takes 5-10 minutes, and findings may guide further diagnostics or treatment, again at the physician's discretion. Receives: Diagnostic Test: Point of care ultrasound |
| Standard examination | No intervention | Participants in the control group will receive a standard clinical assessment, including uptaking the medical history and physical examination of the abdomen and, where clinically indicated, other organ systems, in line with local guidelines. Abdominal POCUS cannot be performed during the ED stay in this group. However, other POCUS modalities (e.g. lung or cardiac ultrasound) or ultrasound performed by a radiologist (after the initial assessment) may still be used if clinically indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct preliminary diagnosis
The primary outcome is the correct preliminary diagnosis, defined as agreement between the enrolling physician's preliminary diagnosis and the final adjudicated diagnosis.
Measured: From enrollment to after 30 days
Secondary outcomes (6)
Inclusion of a correct diagnosis in the differential diagnosis
The proportion of patients in whom the final adjudicated diagnosis is included in the list of differential diagnoses recorded by the physician after the initial clinical assessment.
Measured: From enrollment to after 30 days
Appropriateness of next diagnostic/therapeutic step
The proportion of patients in whom the subsequent diagnostic or therapeutic step is concordant with the final diagnosis.
Measured: From enrollment and the first 24 hours
ED length of stay
Time from randomization to physical departure from the ED.
Measured: From enrollment and til after 30 days
ED re-attendance
Re-attendance to the ED within 7 and 30 days following the index visit.
Measured: From enrollment and till after 30 days
Number of additional diagnostic tests
The number of additional diagnostic tests performed after the initial clinical assessment during the index ED visit.
Measured: From enrollment til after 30 days
Physician-reported diagnostic confidence
Measured using a visual analogue scale from 0-100 following the initial clinical assessment.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Responsible party
- Sponsor
- Investigators
- Jesper B Weile, MD., PhD, Study chair, Dansk: Offentligt hospital (inkl. universitetshospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849569
- Sponsor's protocol ID
- 1-10-72-73-26
- Acronym
- AbdoPOCUS
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, individual participant data underlying the results reported in study publications will be considered for sharing. Data will only be shared with researchers who submit a methodologically sound research proposal, approved by both an independent scientific review committee and the study steering committee, and subject to relevant ethical and data protection regulations (GDPR and the Danish Data Protection Act). Requests for data access should be directed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Point-of-care Ultrasound on Correct Preliminary Diagnosis in Adult Emergency Department Patients With Acute Abdominal Pain: Protocol for a Multicentre, Parallel-group, Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT07849569
- Acronym / sponsor ID
- AbdoPOCUS / 1-10-72-73-26
- Conditions
- Emergency Medicine, POCUS, Abdominal Pain (AP), Acute Abdominal Pain, Ultrasound
- Keywords
- Point of care ultrasound, Emergency department, Emergency physician, Abdominal pain, Acute abdominal pain, Ultrasound, Bedside ultrasound, Emergency medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Sep 2026 (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 goal of this clinical trial is to learn if adding an abdominal ultrasound scan to the standard examination helps emergency physicians make a correct diagnosis in adults with acute abdominal pain in the emergency department. The main question it aims to answer is:
Does adding an abdominal point of care ultrasound scan to the standard examination increase the number of patients with acute abdominal pain in the emergency department, who get a correct preliminary diagnosis?
Researchers will compare patients examined with an abdominal point-of-care ultrasound scan in addition to the standard examination to patients examined with the standard examination alone, to see if adding ultrasound improves diagnostic accuracy.
Participants will:
- Be randomly assigned to also have an abdominal point-of-care ultrasound scan performed by their doctor, or not
- Have their doctor record a preliminary diagnosis and differential diagnosis
- Have their medical records reviewed by an independent panel 30 days after their visit, to determine their final diagnosis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard examination + Abdominal point-of-care ultrasound group (Intervention) | Experimental | Diagnostic Test: Point of care ultrasoundParticipants in the intervention group will undergo an abdominal point-of-care ultrasound examination in addition to the standard clinical examination. The scan will be performed by the enrolling physician as part of the initial bedside assessment, with timing, workflow, equipment, transducer, and preset left to the physician's discretion. The examination typically takes 5-10 minutes, and findings may guide further diagnostics or treatment, again at the physician's discretion. |
| Standard examination | No intervention | –Participants in the control group will receive a standard clinical assessment, including uptaking the medical history and physical examination of the abdomen and, where clinically indicated, other organ systems, in line with local guidelines. Abdominal POCUS cannot be performed during the ED stay in this group. However, other POCUS modalities (e.g. lung or cardiac ultrasound) or ultrasound performed by a radiologist (after the initial assessment) may still be used if clinically indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ED contact.
- Age ≥18 years.
- Non-traumatic, acute abdominal pain, defined as symptom onset ≤7 days prior to presentation, as chief complaint.
- Ability to provide written informed consent, as judged by the enrolling physician, and to communicate in Danish or English.
Key exclusion criteria (6 listed)
- Prior enrollment in the trial.
- Patients in whom the cause of the current abdominal pain is considered known at the time of enrolment (previously diagnosed condition explaining the current symptoms, e.g. known symptomatic gallstone disease).
- Prior physician assessment of the presenting abdominal complaint during the current ED visit.
- Prior ED assessment or received an abdominal ultrasound or CT scan for the same complaint, within the preceding 7 days.
- Chronic abdominal pain, defined as abdominal pain persisting or recurring for ≥3 months(17), where the current episode represents an exacerbation of the chronic condition.
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 ultrasoundThe abdominal point-of-care ultrasound examination is performed by the enrolling emergency physician at the bedside, as part of the initial assessment, rather than by a radiologist or sonographer. The examination follows a standardized scanning protocol developed by the study steering committee, covering conditions that are common or critical in the emergency department, accessible to point-of-care ultrasound, and supported by evidence on diagnostic accuracy. The examination typically takes 5 to 10 minutes. Findings may guide further diagnostics or treatment at the physician's discretion. | Diagnostic test | Standard examination + Abdominal point-of-care ultrasound group (Intervention) |
Primary outcome
Correct preliminary diagnosis
Time frame: From enrollment to after 30 days
The primary outcome is the correct preliminary diagnosis, defined as agreement between the enrolling physician's preliminary diagnosis and the final adjudicated diagnosis.
6 secondary outcomes
Inclusion of a correct diagnosis in the differential diagnosis
Time frame: From enrollment to after 30 days
Appropriateness of next diagnostic/therapeutic step
Time frame: From enrollment and the first 24 hours
ED length of stay
Time frame: From enrollment and til after 30 days
ED re-attendance
Time frame: From enrollment and till after 30 days
Number of additional diagnostic tests
Time frame: From enrollment til after 30 days
Physician-reported diagnostic confidence
Time frame: At enrollment
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Upon completion of the study, individual participant data underlying the results reported in study publications will be considered for sharing. Data will only be shared with researchers who submit a methodologically sound research proposal, approved by both an independent scientific review committee and the study steering committee, and subject to relevant ethical and data protection regulations (GDPR and the Danish Data Protection Act). Requests for data access should be directed to the principal investigator.
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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.
Jesper B Weile, MD., PhD study chair
Dansk: Offentligt hospital (inkl. universitetshospital)
3 sites 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 Emergency Medicine and POCUS, run by University of Aarhus at 3 sites in Denmark.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 Ronja L Larsen, MD (+4553609104, ronlar@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct preliminary diagnosis (time frame: From enrollment to after 30 days). 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 30 Sep 2026.