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OpenTrials
Completed

NCT Number: NCT07535294

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.

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Key information

Conditions

Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Signs and Symptoms, Digestive

Age range

8 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females aged 8 - 21 years presenting to the Emergency Department with lower abdominal pain and with an order for a transabdominal pelvic ultrasound.

Exclusion criteria

  • 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

Treatment and study plan

Experimental AI POCUS

Other

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 Ultrasound

Diagnostic Test

care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Other

Registry information

Official study title

Bladder Point-of-Care Ultrasound to Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence

Acronym: AI-POCUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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