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

Part of paid clinical trials in Miami, Florida.

Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Study ID
NCT07535294
Status
Completed

Conditions

  • Abdominal Pain
  • Pelvic Pain

Eligibility Criteria

Sex
FEMALE
Age
8 Years - 21 Years
Healthy Volunteers
Not accepted

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).
  • Standard of Care Ultrasound — DIAGNOSTIC_TEST
    care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness.

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Apr 2026
Primary completion
Jan 30, 2026
Completion
Feb 11, 2026

Study Design

Enrollment
520 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: AI Pocus
    Patients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements
  • Active Comparator: Standard transabdominal pelvic ultrasound
    Patients will follow the standard of care for ultrasound

Primary Outcome Measure

AI-POCUS assessment of bladder volume [ Time Frame: From enrollment to Pelvic Ultrasound ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nicklaus Children's HospitalMiamiFlorida33155-

Find similar trials in Miami, FL

By research site
Nicklaus Children's Hospital· Miami, FL

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