Trial Outcomes & Findings for Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System (NCT NCT03096483)

NCT ID: NCT03096483

Last Updated: 2019-03-27

Results Overview

Per-subject investigator report for procedure completion using the Investigational Device

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 2 Months
• Results posted on: 2019-03-27

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by site	1

Baseline Characteristics

Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

Baseline characteristics by cohort

Measure	OEC Elite Imaging Arm n=12 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Months

Population: Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.

Per-subject investigator report for procedure completion using the Investigational Device

Outcome measures

Measure	OEC Elite Imaging Arm n=11 Participants 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
Imaging Guidance Adequacy Assessed by Number of Questionnaires	11 Image Guidance Adequacy Questionnaire

SECONDARY outcome

Timeframe: 2 months

Population: Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.

The total number of per subject survey completion reflecting the investigator opinion of procedures completed with the investigational device

Outcome measures

Measure	OEC Elite Imaging Arm n=11 Participants 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
Number of Investigator Procedure Surveys Assessed by Survey Questionnaire	11 Procedure Survey Questionnaire

Adverse Events

OEC Elite Imaging Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Heckel

GE Healthcare

Phone: 2623127269

Email: beth.heckel@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee The results of this study may not be used in future publications.
• Publication restrictions are in place

Restriction type: OTHER