NCT05245851

Clinical Deployment and Validation of Rho

Clinical Deployment and Validation of Rho - An Opportunistic Osteoporosis Screening Software-as-a-Medical Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,146 (actual)
• Sponsor: 16 Bit Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Bone Density

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-21
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2022-02-18
• Last updated: 2025-08-19

Locations

2 sites across 1 country: Canada