Clinical Deployment and Validation of Rho

Last updated: January 23, 2023
Sponsor: 16 Bit Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-menopausal Osteopenia

Osteoporosis

Osteopenia

Treatment

N/A

Clinical Study ID

NCT05245851
Rho_Pilot_PPV_341462
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • age < 50 years
  • inpatient

Study Design

Total Participants: 1200
Study Start date:
November 21, 2022
Estimated Completion Date:
July 21, 2023

Study 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.

Connect with a study center

  • Holland Orthopaedic & Arthritic Centre

    Toronto, Ontario M4Y 1H1
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

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