Interventional Vascular Conditions
Conditions
Brief summary
The purpose of this study is to collect feedback on imaging guidance adequacy from physicians who use the OEC™ 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.
Interventions
DEVICEFluoroscopic 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.
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old); 2. Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance; 3. Able and willing to comply with study procedures; and 4. Able and willing to provide written informed consent to participate.
Exclusion criteria
1. Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator; 2. Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or 3. Previously participated in this study, or enrolled in another active GEHC study or other research study that could be expected to interfere with participation in study procedures, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Guidance Adequacy Collected Via Survey Questionnaire | Approximately 2 months (duration of subject enrollment) | Number of participants whose procedures were completed using the investigational device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | Approximately 2 months (duration of subject enrollment) | To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Continuous | 69.9 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Image Guidance Adequacy Collected Via Survey Questionnaire
Number of participants whose procedures were completed using the investigational device.
Time frame: Approximately 2 months (duration of subject enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Image Guidance Adequacy Collected Via Survey Questionnaire | 30 Participants |
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.
Time frame: Approximately 2 months (duration of subject enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | 30 Participants |