Hip Injury, Tibial Fracture, Wrist Injury
Conditions
Keywords
TOMOSYNTHESIS
Brief summary
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
Detailed description
Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.
Interventions
DEVICEStandard X-Ray + CT
Standard of Care X-Ray Imaging + CT
DEVICEStandard X-Ray + MRI
Standard of Care X-Ray Imaging + MRI
DEVICETOMO
Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Sponsors
Fujifilm Medical Systems USA, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Physician request to have diagnostic imaging for condition areas
Exclusion criteria
* Under 18 * Pregnancy * Insufficient Anatomical Coverage or Potential Image Problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Whom Tibia Injury Was Detected | Baseline Imaging Collection | Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems. |
Countries
United States
Participant flow
Recruitment details
Subjects who present for, are undergoing, or have undergone 'standard of care' general x-ray and CT or MRI examinations, which meet all of the study enrollment criteria, may be approached and enrolled. Each subject would then have a 3rd image taken using Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.
Pre-assignment details
Subjects are recruited as long as they had either an x-ray and CT or an x-ray and MRI, and sign a consent to have a third image taken with Fujifilm's Digital Radiographic AcSelerate CsI System with Tomosynthesis.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT
Followed by Tomo Imaging | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 54 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Number of Participants for Whom Tibia Injury Was Detected
Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.
Time frame: Baseline Imaging Collection
Population: Three sets (1 - X-ray, 1- CT and 1 - Digital Tomosynthesis) of images of the tibia evaluated to confirm acceptable image quality and provided clinical and diagnostic value.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard X-Ray | Number of Participants for Whom Tibia Injury Was Detected | 1 participants |
| Standard CT | Number of Participants for Whom Tibia Injury Was Detected | 1 participants |
| Tomosynthesis | Number of Participants for Whom Tibia Injury Was Detected | 1 participants |