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

NCT07535294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

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).

DIAGNOSTIC_TEST

Standard of Care Ultrasound

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Paul Khalil, MD · Nicklaus Children's Hospital fka Miami Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2026-01-30
Completion
2026-02-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535294 on ClinicalTrials.gov