Validating Osteoporosis Detection in Rho AI Software
NCT06830005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2026-01-15
Summary
To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.
Conditions
- Osteopenia or Osteoporosis
Interventions
- DEVICE
-
Rho AI software
Rho is a AI enabled opportunistic pre-screening computer-aided detection and notification software for low bone mineral density.
Sponsors & Collaborators
-
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
James Bernatz, MD · UW School of Medicine and Public Health
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2025-12-01
- Completion
- 2025-12-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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