Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence (AI-POCUS)

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Pelvic Pain
• Intervention / Treatment: Other: Experimental AI POCUS; Diagnostic test: Standard of Care 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 Type: Interventional
• Enrollment (Actual): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI Pocus; Patients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements	Other: Experimental AI POCUS; 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).
Active Comparator: Standard transabdominal pelvic ultrasound; Patients will follow the standard of care for ultrasound	Diagnostic test: Standard of Care Ultrasound; care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to Pelvic Ultrasound

Collaborators and Investigators

• Sponsor: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
• Investigators: Principal Investigator: Paul Khalil, MD, Nicklaus Children's Hospital fka Miami Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): February 11, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: children; abdominal pain; pelvic pain; AI POCUS
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Pelvic Pain
• Other Study ID Numbers: 20242629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical Study Report
• IPD Sharing Time Frame: Starting 4-13-26, ending 4-13-28
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes