Clinical Deployment and Validation of Rho

NACompletedINTERVENTIONAL
Enrollment

1,146

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

October 1, 2023

Study Completion Date

October 1, 2023

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."

Trial Locations (2)

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M4Y 1H1

Holland Orthopaedic & Arthritic Centre, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Sunnybrook Health Sciences Centre

OTHER

lead

16 Bit Inc.

INDUSTRY

NCT05245851 - Clinical Deployment and Validation of Rho | Biotech Hunter | Biotech Hunter