Abdominal PainAI-POCUSNCT07535294
Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence
A study testing Experimental AI POCUS in people with Abdominal Pain and Pelvic Pain, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
Trial summary
Point-of-Care Ultrasound (POCUS) is a relatively quick and non-invasive technique to assess bladder fullness which will be provided under standard of care. The goal of this study is to assess for bladder fullness by measuring bladder volume using a handheld POCUS with AI technology to objectively determine patient… Read more about this study
- Who is it for?
- Ages 8 to 21 years, women only
- Conditions the study is for
- Abdominal Pain, Pelvic Pain
- What is being tested?
- Experimental AI POCUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 11 Feb 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 8 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females aged 8 - 21 years presenting to the Emergency Department with lower abdominal pain and with an order for a transabdominal pelvic ultrasound.
Who cannot join
- Patients less than 8 years or greater than 21 years
- Males
- Patients with a history of anatomical anomalies or known pregnancy
- Patients that are critically ill, non-verbal or with significant developmental delay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bladder Point-of-Care Ultrasound to Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence
Point-of-Care Ultrasound (POCUS) is a relatively quick and non-invasive technique to assess bladder fullness which will be provided under standard of care. The goal of this study is to assess for bladder fullness by measuring bladder volume using a handheld POCUS with AI technology to objectively determine patient readiness for pelvic ultrasound.
Read the detailed description
Nicklaus Children's Hospital's researches want to determine if the AI-POCUS assessment of bladder volume can shorten the time to transabdominal pelvic ultrasound. The primary objective is the time to transabdominal pelvic ultrasound (calculated from the time the ultrasound was ordered to when the ultrasound was started in Radiology). This information will be used to guide strategies for improvements in our care to patients.
- Conditions
- Abdominal Pain, Pelvic Pain
- Being tested
- Experimental AI POCUS, Standard of Care Ultrasound
- Keywords
- abdominal pain, pelvic pain, AI POCUS, children
- Medical subject headings
- Abdominal Pain, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental AI POCUSOther
Patients will be randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements every 30 minutes until the bladder is considered subjectively full or until 350-mL has been reached (whichever comes first).
Standard of Care UltrasoundDiagnostic test
care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness.
| Study group | Role | What they receive |
|---|---|---|
| AI Pocus | Experimental | Patients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements Receives: Other: Experimental AI POCUS |
| Standard transabdominal pelvic ultrasound | Active comparator | Patients will follow the standard of care for ultrasound Receives: Diagnostic Test: Standard of Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
AI-POCUS assessment of bladder volume
This study aims to determine whether AI-POCUS assessment of bladder volume can expedite transabdominal pelvic ultrasound. The primary objective is time to transabdominal pelvic ultrasound (calculated from time the ultrasound was ordered to when the ultrasound was started in Radiology).
Measured: From enrollment to Pelvic Ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start14 Aug 2024
- Primary completion30 Jan 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Khalil, M.D., Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Investigators
- Paul Khalil, MD, Principal investigator, Nicklaus Children's Hospital fka Miami Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535294
- Sponsor's protocol ID
- 20242629
- Acronym
- AI-POCUS
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Point-of-Care Ultrasound to Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07535294
- Acronym / sponsor ID
- AI-POCUS / 20242629
- Conditions
- Abdominal Pain, Pelvic Pain
- Keywords
- abdominal pain, pelvic pain, AI POCUS, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 17 Apr 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.
Point-of-Care Ultrasound (POCUS) is a relatively quick and non-invasive technique to assess bladder fullness which will be provided under standard of care. The goal of this study is to assess for bladder fullness by measuring bladder volume using a handheld POCUS with AI technology to objectively determine patient readiness for pelvic ultrasound.
Detailed description
Nicklaus Children's Hospital's researches want to determine if the AI-POCUS assessment of bladder volume can shorten the time to transabdominal pelvic ultrasound. The primary objective is the time to transabdominal pelvic ultrasound (calculated from the time the ultrasound was ordered to when the ultrasound was started in Radiology). This information will be used to guide strategies for improvements in our care to patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Pocus | Experimental | Other: Experimental AI POCUSPatients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements |
| Standard transabdominal pelvic ultrasound | Active comparator | Diagnostic Test: Standard of Care UltrasoundPatients will follow the standard of care for ultrasound |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Females aged 8 - 21 years presenting to the Emergency Department with lower abdominal pain and with an order for a transabdominal pelvic ultrasound.
Key exclusion criteria (4 listed)
- Patients less than 8 years or greater than 21 years
- Males
- Patients with a history of anatomical anomalies or known pregnancy
- Patients that are critically ill, non-verbal or with significant developmental delay
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 |
|---|---|---|
| Experimental AI POCUSPatients will be randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements every 30 minutes until the bladder is considered subjectively full or until 350-mL has been reached (whichever comes first). | Other | AI Pocus |
| Standard of Care Ultrasoundcare group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness. | Diagnostic test | Standard transabdominal pelvic ultrasound |
Primary outcome
AI-POCUS assessment of bladder volume
Time frame: From enrollment to Pelvic Ultrasound
This study aims to determine whether AI-POCUS assessment of bladder volume can expedite transabdominal pelvic ultrasound. The primary objective is time to transabdominal pelvic ultrasound (calculated from time the ultrasound was ordered to when the ultrasound was started in Radiology).
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Clinical Study Report
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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.
Paul Khalil, MD principal investigator
Nicklaus Children's Hospital fka Miami Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental AI POCUS in people with Abdominal Pain and Pelvic Pain, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
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 24 Apr 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 United States. 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?
AI-POCUS assessment of bladder volume (time frame: From enrollment to Pelvic Ultrasound). 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 24 Apr 2026.