Clinical Deployment and Validation of Rho

Not Applicable

Recruiting

• Conditions: Low Bone Density
• Interventions: Device: Opportunistic screening for low BMD

• Registration Number: NCT05245851
• Lead Sponsor: 16 Bit Inc.

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.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-18
• Study Start: 2022-11-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opportunistic screening for low BMD	Opportunistic screening for low BMD	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.

Primary Outcome Measures

Name	Time	Method
Positive predictive value	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 Outcome Measures

Name	Time	Method
DXA conversion	9 months	To assess the DXA conversion rate defined as the proportion of patients who have a DXA within 6 months following a positively reported RhoTM screen. Scheduled DXA examinations may be used as a surrogate.

Trial Locations

Locations (2)

Holland Orthopaedic & Arthritic Centre; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada