NCT07535294

Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital · Academic / Other
• Sex: Female
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Abdominal Pain
• Pelvic Pain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI Pocus	Patients in the experimental group will undergo bladder volume measurements using POCUS with AI (EXO Iris) every 30 minutes from the time the pelvic ultrasound was ordered until the bladder is considered subjectively full or until 350-mL has been reached (whichever comes first).

Timeline

• Start date: 2024-08-14
• Primary completion: 2026-01-30
• Completion: 2026-02-11
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study