Clinical Deployment and Validation of Rho

16 Bit

Status: Completed

Conditions: Low Bone Density

Treatments: Device: Opportunistic screening for low BMD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05245851

Rho_Pilot_PPV_341462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,146 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 50+ years
• outpatient undergoing x-ray examinations of:
• chest
• thoracic spine
• lumbar spine
• pelvis
• knee
• hand/wrist

Exclusion criteria

• age < 50 years
• inpatient

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,146 participants in 1 patient group

Opportunistic screening for low BMD

Experimental group

Description:

Outpatients aged over 50 years undergoing x-ray of the thoracic spine, lumbar spine, chest, pelvis, hand or knee will have their x-rays screened for low BMD by the software-as-a-medical device. If low BMD is identified by the software, a radiologist reviewing the x-ray may choose to incorporate this as an incidental finding in their report to the referring physician.

Treatment:

Device: Opportunistic screening for low BMD