Clinical Deployment and Validation of Rho

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validating Osteoporosis Detection in Rho AI Software

NCT06830005

Osteopenia or Osteoporosis

COMPLETED NA

Immunophenotyping in Patients With Osteoporosis

NCT05132348

Immunophenotyping Blood Samples of Patients With Osteoporosis

RECRUITING

Assessment of Cortical Bone Mechanics Technology (CBMT) Fracture Discrimination Capability

NCT05721898

Osteoporosis Osteopenia or Osteoporosis Osteoporosis, Postmenopausal +4 more

COMPLETED

Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip Replacement

NCT02576652

Osteoporosis

COMPLETED PHASE4

3D Imaging of the Hip Using DXA

NCT00666640

Osteoporosis Low-energy Trauma Fracture

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Low Bone Density

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

16 Bit intends to study the impact of RhoTM by performing a prospective trial to assess its impact. A selected pilot site must have both x-ray and dual energy x-ray absorptiometry (DXA) imaging services, with the anticipation that DXA referrals will be made to the same imaging center which performed the x-ray which underwent RhoTM screening. The study population to assess the impact of RhoTM will consist of patients aged 50 and above who are opportunistically screened by RhoTM while undergoing an x-ray of the lumbar spine, thoracic spine, hand, knee, pelvis or chest.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Opportunistic screening for low BMD

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE