Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-arm group | Active Comparator | The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment. |
|
| Test-arm group | Experimental | The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTS | Device | Subjects undergo wrist imaging using DTS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of X-ray Images | collection of image sets from X-ray imaging exams for each complete and evaluable subject case | 1 year |
| Number of DTS images | Collection of image sets from DTS imaging exams for each complete and evaluable subject case | 1 year |
| Number of CT (or MRI) images | collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire about Diagnosis | collection of subject diagnosis (positive, negative, or inconclusive) for each complete and evaluable subject case | 1 year |
| Questionnaire about Treatment | collection of treatment information (no treatment necessary, non-operative, operative) for each complete and evaluable subject case |
Not provided
Inclusion Criteria for Control-arm Subjects:
Subjects who meet all of the following inclusion criteria may be enrolled in this study:
Exclusion Criteria for Control-arm Subjects:
Subjects who meet any of the following exclusion criteria will be excluded from this study:
Inclusion Criteria for Test-arm Subjects:
Subjects who meet all of the following inclusion criteria may be enrolled in this study:
Exclusion Criteria for Test-arm Subjects:
Subjects who meet any of the following exclusion criteria will be excluded from this study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Dooley | Contact | (215)-294-9650 | Mary.Dooley@uphs.upenn.edu | |
| David Steinberg, MD | Contact | (856)-220-6985 | David.Steinberg@uphs.upenn.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Hospital - Department of Orthopaedic Surgery | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Feb 1, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
Not provided
Not provided
| ID | Term |
|---|---|
| D008327 | Mammography |
| D003952 | Diagnostic Imaging |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| X-ray | Device | Subjects undergo wrist imaging using standard X-ray imaging. |
|
|
| MRI or CT | Device | Subjects may undergo wrist imaging using MRI or CT. |
|
|
| 1 year |