Interventional Vascular Conditions
Conditions
Brief summary
The purpose of the study is to collect survey data on the use of the OEC Elite Mobile Fluoroscopy System based on the routine clinical use of the device.
Detailed description
This prospective clinical study is being conducted to acquire image guidance adequacy data from physicians conducting clinically-indicated vascular, gastrointestinal (GI), urology and pain management procedures for engineering use, as deemed appropriate by the Sponsor, for the investigational OEC Elite Mobile Fluoroscopy System (OEC Elite) in the vascular configuration. Clinical procedures included in this study will involve three (3) anatomical regions of interest - extremities and neck, thorax, and abdomen and pelvis. These regions are being targeted because they represent the range of clinical applications and anatomical regions intended for OEC Elite in the vascular configuration.
Interventions
DEVICEOEC Elite system
Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old); 2. Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed; 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 |
|---|---|---|
| Imaging Guidance Adequacy Assessed by Number of Questionnaires | 2 Months | Per-subject investigator report for procedure completion using the Investigational Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | 2 months | The total number of per subject survey completion reflecting the investigator opinion of procedures completed with the investigational device |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OEC Elite Imaging Arm Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system
OEC Elite system: Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by site | 1 |
Baseline characteristics
| Characteristic | OEC Elite Imaging Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Imaging Guidance Adequacy Assessed by Number of Questionnaires
Per-subject investigator report for procedure completion using the Investigational Device
Time frame: 2 Months
Population: Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OEC Elite Imaging Arm | Imaging Guidance Adequacy Assessed by Number of Questionnaires | 11 Image Guidance Adequacy Questionnaire |
Secondary
Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
The total number of per subject survey completion reflecting the investigator opinion of procedures completed with the investigational device
Time frame: 2 months
Population: Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OEC Elite Imaging Arm | Number of Investigator Procedure Surveys Assessed by Survey Questionnaire | 11 Procedure Survey Questionnaire |