Trial Outcomes & Findings for Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital (NCT NCT03417713)
NCT ID: NCT03417713
Last Updated: 2018-11-29
Results Overview
Number of participants whose procedures were completed using the investigational device.
Recruitment status
COMPLETED
Target enrollment
33 participants
Primary outcome timeframe
Approximately 2 months (duration of subject enrollment)
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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33
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Subjects
n=30 Participants
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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|---|---|
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Age, Continuous
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69.9 Years
n=30 Participants
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Sex: Female, Male
Female
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9 Participants
n=30 Participants
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Sex: Female, Male
Male
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21 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: Approximately 2 months (duration of subject enrollment)Number of participants whose procedures were completed using the investigational device.
Outcome measures
| Measure |
All Subjects
n=30 Participants
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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|---|---|
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Image Guidance Adequacy Collected Via Survey Questionnaire
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30 Participants
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Subjects
n=30 Participants
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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|---|---|
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Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
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30 Participants
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Adverse Events
All Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Subjects
n=30 participants at risk
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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|---|---|
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Skin and subcutaneous tissue disorders
Hematoma
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3.3%
1/30 • Number of events 1 • Adverse events were collected from when the subject entered the study to when they completed study procedures
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place