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Sponsor decision to close trial
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard X-Ray + CT | Active Comparator | 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 + MRI | Active Comparator | Standard X-Ray + MRI 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. |
|
| Tomo | Experimental | Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard X-Ray + CT | Device | Standard of Care X-Ray Imaging + CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline Imaging Collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davide Bova, MD | Loyola University Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University of Chicago | Maywood | Illinois | 60153 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Standard of care X-Ray imaging plus CT to be compared with research imaging device. Standard X-Ray: Standard of Care X-Ray Imaging + CT Followed by Tomo Imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 patient was enrolled in this study, and they underwent Standard X-Ray and CT as well as Tomosynthesis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | Baseline Imaging Collection |
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1 day; Standard of Care X-ray, CT and Tomo all completed within this day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard X-Ray | Standard of care X-Ray, and CT imaging to be compared with research imaging device. Standard X-Ray: Standard of Care X-Ray Imaging Followed by Tomo imaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Uzenoff | Fujifilm Medical Systems, U.S.A., Inc. | (203) 602-3664 | ruzenoff@fujifilm.com |
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| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D013978 | Tibial Fractures |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D007869 | Leg Injuries |
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| Standard X-Ray + MRI | Device | Standard of Care X-Ray Imaging + MRI |
|
| TOMO | Device | Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard CT | Standard of care CT imaging to be compared with research imaging device. Followed by Tomo imaging No AE's |
| OG002 | Tomosynthesis | Tomosynthesis imaging to be compared to standard of care CT and X-ray No AEs |
|
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Standard CT | Standard of care X-Ray, and CT imaging to be compared with research imaging device. Standard X-Ray: Standard of Care X-Ray Imaging Followed by Tomo imaging | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Tomo | Standard of care X-Ray, and CT imaging to be compared with research imaging device. Standard X-Ray: Standard of Care X-Ray Imaging Followed by Tomo imaging | 0 | 1 | 0 | 1 | 0 | 1 |
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