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The purpose of this study is to collect feedback on imaging guidance adequacy from physicians who use the OECâ„¢ Elite CFD Mobile Fluoroscopy System-Motorized Configuration to perform surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of care.
Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device.
Following completion of each subject's procedure, the investigators will complete a User Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey will consist of a series of questions on the use of the system as well as anonymized image data.
After all subjects' procedures are completed at a given site, the site investigator will review survey data from the study subjects enrolled at the site and document his/her assessment of the overall acceptability of the system for use in a clinical environment.
There is no statistical hypothesis being tested in this study. Results will be summarized using descriptive statistics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopic imaging with the OEC Elite Device | Device | Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Guidance Adequacy Collected Via Survey Questionnaire | Number of participants whose procedures were completed using the investigational device. | Approximately 2 months (duration of subject enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures. | Approximately 2 months (duration of subject enrollment) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite. Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite. Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Image Guidance Adequacy Collected Via Survey Questionnaire | Number of participants whose procedures were completed using the investigational device. | Posted | Count of Participants | Participants | Approximately 2 months (duration of subject enrollment) |
|
|
Adverse events were collected from when the subject entered the study to when they completed study procedures
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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 | All Subjects | This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite. Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Rapanos | Hamilton General Hospital | 905-521-2100 | 44652 | rapanost@mcmaster.ca |
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| 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 20, 2017 | Jul 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005471 | Fluoroscopy |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
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| Secondary | Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures. | Posted | Count of Participants | Participants | Approximately 2 months (duration of subject enrollment) |
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
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