Abdominal DiseasesNCT07497490
A Study of the Time to Diagnosis by Hand-held Abdominal Ultrasound in In-patient Settings
A study testing Portable Ultrasound in people with Abdominal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this study is to investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the impact of hospital length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Diseases
- What is being tested?
- Portable Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2024to 31 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 who are hospitalized and requiring for a gastroenterology consultation or abdominal ultrasound, including cases of abdominal pain, diarrhea, abnormal liver function, unexplained fever, or evaluating intra-abdominal lesions.
Who cannot join
- Patients unable to comply with handheld ultrasound examination.
- Patients who are in the intensive care unit.
- Patients who had already undergone formal abdominal imaging within one week prior to the consultation.
- Patients who referred for immediate endoscopic intervention, such as active gastrointestinal bleeding or foreign body ingestion.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the impact of hospital length of stay.
Read the detailed description
The utilization of handheld ultrasound in the diagnosis and treatment of acute diseases has been practiced for many years, and in certain scenarios, its efficacy is comparable to that of traditional ultrasound. The portability and real-time bedside application of handheld ultrasound have made it increasingly significant in the clinical practice of subspecialties such as cardiovascular, thoracic, and hepato- gastroenterology. Consequently, the use of handheld ultrasound during hospitalizations or emergencies may shorten the time required for accurate diagnosis, enabling patients to receive timely treatment.
To investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the commencement of treatment.
This study employs a prospective design with an anticipated enrollment of 200 patients over approximately one year (December 2024 to November 2025). A clustered-randomized controlled trial design will be used to fit real-world clinical scenario, with participants allocated to either an intervention group (current consultation model supplemented with handheld ultrasound) or a control group by odd/even-numbered calendar days. The primary outcome will be the speed of diagnostic imaging between the two groups. Secondary outcomes will include other indicators of inpatient care quality, such as length of hospital stay and diagnostic accuracy.
- Conditions
- Abdominal Diseases
- Being tested
- Portable Ultrasound
- Keywords
- Handheld ultrasound, Abdominal diseases, Gastrointestinal and hepatology consultation, In-patient, Hospita length of stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable UltrasoundDiagnostic test
A handheld portable ultrasound sponsored by Aco Healthcare Co., Ltd company
| Study group | Role | What they receive |
|---|---|---|
| Handheld Ultrasound/POCUS Arm | Experimental | Not described Receives: Diagnostic Test: Portable Ultrasound |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnostic imaging
This outcome evaluates the clinical efficiency of the diagnostic workflow by measuring the time interval (in minutes) required to complete the initial diagnostic imaging.
The exact measurement endpoints are defined by the study arm:
Start point (Both arms): The exact time the gastroenterology consultation is initiated.
End point (Intervention group): Defined as the interval from the consultation request to the first modality that established the correct diagnosis of the targeted organs matching the final electronic medical record. If the bedside POCUS findings accurately identified the primary pathology, the POCUS timestamp was used; otherwise, the timestamp of the subsequent formal radiology report was utilized.
End point (Control group): The execution of the first formally scheduled diagnostic imaging study (e.g., computed tomography [CT], magnetic resonance imaging [MRI], or conventional cart-based ultrasound) ordered as part of standard care following the consultation.
Measured: From the initiation of the consultation to the execution of the diagnostic imaging study, assessed up to hospital discharge (an average of 14 to 30 days).
Secondary outcomes (2)
Post-Consultation Hospital Length of Stay (LOS)
This outcome evaluates the impact of the intervention on overall hospital resource utilization by measuring the post-consultation length of stay.
The post-consultation LOS is defined as the time interval (measured in days) starting from the exact date the gastroenterology consultation is initiated (baseline) to the date the patient is officially discharged from the hospital.
Data will be collected for both the intervention group (HUD) and the control group (standard care). Group differences will be analyzed to determine if the expedited point-of-care diagnostic workflow associated with the intervention effectively reduces the remaining hospitalization days. To account for skewed clinical data, comparisons will be reported using median days with interquartile ranges (IQR) and adjusted rate ratios.
Measured: From the initiation of the gastroenterology consultation to the date of hospital discharge, assessed up to a maximum of 1 year.
Diagnostic Accuracy of the Targeted Organ by Handheld Ultrasound Device (HUD)
This outcome evaluates the diagnostic accuracy of the initial point-of-care evaluation using a HUD. Accuracy is determined by comparing HUD findings (Index Test) against the final definitive diagnosis (Reference Standard).
Index Test: The primary pathology recorded by the consultant immediately following the bedside HUD examination.
Reference Standard: The final clinical diagnosis of the targeted organ (e.g., biliary tract, liver, pancreas) established prior to discharge. This is confirmed by subsequent formal imaging (e.g., comprehensive ultrasound, CT, MRI).
Accuracy is reported as the percentage of HUD evaluations correctly matching the reference standard.
Measured: From the time of initial HUD evaluation up to hospital discharge (an average of 2 to 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Dec 2024
- Primary completion30 Nov 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aco Healthcare Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497490
- Sponsor's protocol ID
- 25626
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available from the corresponding author upon reasonable request.
Publications
Barreiros AP, Dong Y, Ignee A, Wastl D, Dietrich CF. EchoScopy in scanning abdominal diseases; a prospective single center study. Med Ultrason. 2019 Feb 17;21(1):8-15. doi: 10.11152/mu-1907.
PubMed 30779825
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Time to Diagnosis by Hand-held Abdominal Ultrasound in In-patient Settings
- ClinicalTrials.gov ID
- NCT07497490
- Acronym / sponsor ID
- 25626
- Conditions
- Abdominal Diseases
- Keywords
- Handheld ultrasound, Abdominal diseases, Gastrointestinal and hepatology consultation, In-patient, Hospita length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Aco Healthcare Co., Ltd.
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 27 Mar 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 study is to investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the impact of hospital length of stay.
Detailed description
The utilization of handheld ultrasound in the diagnosis and treatment of acute diseases has been practiced for many years, and in certain scenarios, its efficacy is comparable to that of traditional ultrasound. The portability and real-time bedside application of handheld ultrasound have made it increasingly significant in the clinical practice of subspecialties such as cardiovascular, thoracic, and hepato- gastroenterology. Consequently, the use of handheld ultrasound during hospitalizations or emergencies may shorten the time required for accurate diagnosis, enabling patients to receive timely treatment.
To investigate the impact of integrating handheld abdominal ultrasound into the current gastroenterology and hepatology consultation model at our hospital, particularly in terms of the speed of diagnostic evaluation and the commencement of treatment.
This study employs a prospective design with an anticipated enrollment of 200 patients over approximately one year (December 2024 to November 2025). A clustered-randomized controlled trial design will be used to fit real-world clinical scenario, with participants allocated to either an intervention group (current consultation model supplemented with handheld ultrasound) or a control group by odd/even-numbered calendar days. The primary outcome will be the speed of diagnostic imaging between the two groups. Secondary outcomes will include other indicators of inpatient care quality, such as length of hospital stay and diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Handheld Ultrasound/POCUS Arm | Experimental | Diagnostic Test: Portable Ultrasound |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged over 18 who are hospitalized and requiring for a gastroenterology consultation or abdominal ultrasound, including cases of abdominal pain, diarrhea, abnormal liver function, unexplained fever, or evaluating intra-abdominal lesions.
Key exclusion criteria (4 listed)
- Patients unable to comply with handheld ultrasound examination.
- Patients who are in the intensive care unit.
- Patients who had already undergone formal abdominal imaging within one week prior to the consultation.
- Patients who referred for immediate endoscopic intervention, such as active gastrointestinal bleeding or foreign body ingestion.
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 |
|---|---|---|
| Portable UltrasoundA handheld portable ultrasound sponsored by Aco Healthcare Co., Ltd company | Diagnostic test | Handheld Ultrasound/POCUS Arm |
Primary outcome
Time to diagnostic imaging
Time frame: From the initiation of the consultation to the execution of the diagnostic imaging study, assessed up to hospital discharge (an average of 14 to 30 days).
This outcome evaluates the clinical efficiency of the diagnostic workflow by measuring the time interval (in minutes) required to complete the initial diagnostic imaging. The exact measurement endpoints are defined by the study arm: Start point (Both arms): The exact time the gastroenterology consultation is initiated. End point (Intervention group): Defined as the interval from the consultation request to the first modality that established the correct diagnosis of the targeted organs matching the final electronic medical record. If the bedside POCUS findings accurately identified the primary pathology, the POCUS timestamp was used; otherwise, the timestamp of the subsequent formal radiology report was utilized. End point (Control group): The execution of the first formally scheduled diagnostic imaging study (e.g., computed tomography [CT], magnetic resonance imaging [MRI], or conventional cart-based ultrasound) ordered as part of standard care following the consultation.
2 secondary outcomes
Post-Consultation Hospital Length of Stay (LOS)
Time frame: From the initiation of the gastroenterology consultation to the date of hospital discharge, assessed up to a maximum of 1 year.
Diagnostic Accuracy of the Targeted Organ by Handheld Ultrasound Device (HUD)
Time frame: From the time of initial HUD evaluation up to hospital discharge (an average of 2 to 4 weeks).
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 12 Aug 2026.
- Results publication: PubMed 30779825Barreiros AP, Dong Y, Ignee A, Wastl D, Dietrich CF. EchoScopy in scanning abdominal diseases; a prospective single center study. Med Ultrason. 2019 Feb 17;21(1):8-15. doi: 10.11152/mu-1907.
- Individual participant dataSharing planned: Yes. Available from the corresponding author upon reasonable request.
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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. 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?
A study testing Portable Ultrasound in people with Abdominal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 12 Aug 2026. 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 Taiwan. 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?
Time to diagnostic imaging (time frame: From the initiation of the consultation to the execution of the diagnostic imaging study, assessed up to hospital discharge (an average of 14 to 30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07497490, which also lists 1 linked publication.
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 12 Aug 2026.