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Clinical Deployment and Validation of Rho

NCT05245851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1146

Last updated 2025-08-19

No results posted yet for this study

Summary

Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed software, called RhoTM, that analyzes various x-rays, performed in patient age 50 and above for any clinical indication, to identify patients with low BMD. RhoTM is intended to function as a pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing its performance and impact on DXA referrals.

Conditions

  • Low Bone Density

Interventions

DEVICE

Opportunistic screening for low BMD

Software will analyze x-rays of the chest, thoracic spine, lumbar spine, pelvis, knee or hand/wrist acquired for any reason, and notify the radiologist at time of acquisition if low BMD is detected. The report to the radiologist includes the following statements: * This x-ray was opportunistically analyzed by RhoTM, an investigational device under ITA \[investigational testing authorization\] from Health Canada, to screen for low bone mineral density (low BMD). * This information should be used by a trained healthcare provider in conjunction with a patient's clinical fracture risk to determine if formal BMD screening with DXA is appropriate. The radiologist can choose to include this as an incidental finding in their report to the referring physician.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • 16 Bit Inc.

    lead INDUSTRY

Principal Investigators

  • Anastasia Oikonomou, MD, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT05245851 on ClinicalTrials.gov