Clinical Deployment and Validation of Rho - An Opportunistic Osteoporosis Screening Software-as-a-Medical Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Bone Density
- Sponsor
- 16 Bit Inc.
- Enrollment
- 1146
- Locations
- 2
- Primary Endpoint
- Positive predictive value
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Detailed Description
Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed an opportunistic screening tool for low BMD, called RhoTM, that analyzes lumbar spine, thoracic spine, chest, pelvis, knee, and hand radiographs, performed in patient age 50 and above for any clinical indication to estimate lumbar and femoral neck BMD. The estimated BMD T-score is used to classify patients as having normal or low BMD. A finding of low BMD can be included in a radiologist's report, and is intended to support a discussion between healthcare provider and patient regarding the need for osteoporosis diagnosis by dual-energy x-ray absorptiometry (DXA). In this way, RhoTM is intended to function as an opportunistic 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 the diagnostic performance and impact on DXA referrals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 50+ years
- •outpatient undergoing x-ray examinations of:
- •thoracic spine
- •lumbar spine
- •hand/wrist
Exclusion Criteria
- •age \< 50 years
- •inpatient
Outcomes
Primary Outcomes
Positive predictive value
Time Frame: 9 months
To measure the positive screening rate for all patients screened by RhoTM and the positive predictive value (PPV) in those patients who screen positive by RhoTM and undergo follow-up DXA. PPV will be assessed for identification of low BMD (T-score \<-1) and for identification of moderate/high fracture risk.
Secondary Outcomes
- DXA conversion(9 months)