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

NCT07535294 | Completed FDA Device

• 1 other identifier: 20242629
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Pain; Pelvic Pain

Keywords

abdominal pain; pelvic pain; AI POCUS; children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

AI Pocus

EXPERIMENTAL

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

Standard transabdominal pelvic ultrasound

ACTIVE COMPARATOR

Patients will follow the standard of care for ultrasound

Diagnostic Test: Standard of Care Ultrasound

Interventions

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).

AI Pocus

Standard of Care Ultrasound DIAGNOSTIC_TEST

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

Standard transabdominal pelvic ultrasound

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: lead

Study Sites (1)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

MeSH Terms

Conditions

Abdominal Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Paul Khalil, MD

  Nicklaus Children's Hospital fka Miami Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: August 14, 2024
• Primary Completion: January 30, 2026
• Study Completion: February 11, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Starting 4-13-26, ending 4-13-28

Locations

US (1)