Interventional Vascular ConditionsNCT03417713

Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital

An observational study of Interventional Vascular Conditions, run by GE Healthcare at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Interventional Vascular Conditions
What is being tested?: Fluoroscopic imaging with the OEC Elite Device
Type of treatment: Medical device
How many people: 33 participants
Where: 1 siteCanada
Study dates: 4 Apr 2018to 29 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old);
Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance;
Able and willing to comply with study procedures; and
Able and willing to provide written informed consent to participate.

Who cannot join

Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Hamilton General Hospital
Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures

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.

Conditions: Interventional Vascular Conditions
Being tested: Fluoroscopic imaging with the OEC Elite Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluoroscopic imaging with the OEC Elite DeviceDevice
Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Study groups in NCT03417713
Study group	Role	What they receive
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. Receives: Device: Fluoroscopic imaging with the OEC Elite Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Image Guidance Adequacy Collected Via Survey Questionnaire
Number of participants whose procedures were completed using the investigational device.
Measured: Approximately 2 months (duration of subject enrollment)

Secondary outcomes (1)

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.
Measured: Approximately 2 months (duration of subject enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 201829 May 2018

First posted31 Jan 2018
Study start4 Apr 2018
Primary completion15 May 2018
Study completion29 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Interventional Vascular ConditionsStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03417713
Sponsor's protocol ID: 104-2017-GES-0005
Status last verified: Oct 2018
First submitted: 12 Jan 2018
Last updated: 29 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Interventional Vascular Conditions trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the OEC Elite MD for Vascular Procedures
ClinicalTrials.gov ID: NCT03417713
Acronym / sponsor ID: 104-2017-GES-0005
Conditions: Interventional Vascular Conditions
Study type: Observational
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 4 Apr 2018 (actual)
Primary completion: 15 May 2018 (actual)
Study completion: 29 May 2018 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 29 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device.

There is no statistical hypothesis being tested in this study. Results will be summarized using descriptive statistics.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Subjects	–	Device: Fluoroscopic imaging with the OEC Elite DeviceThis 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (4 listed)

Male or female between the ages of 18 and 85 years (≥18 and ≤85 years old);
Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance;
Able and willing to comply with study procedures; and
Able and willing to provide written informed consent to participate.

Key exclusion criteria (3 listed)

Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluoroscopic imaging with the OEC Elite DeviceVascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.	Device	All Subjects

Primary outcome

Image Guidance Adequacy Collected Via Survey Questionnaire
Time frame: Approximately 2 months (duration of subject enrollment)
Number of participants whose procedures were completed using the investigational device.

1 secondary outcome

Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
Time frame: Approximately 2 months (duration of subject enrollment)

Results and safety

Results posted to the registry on 29 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	33	30

Primary outcome: Image Guidance Adequacy Collected Via Survey Questionnaire

Time frame: Approximately 2 months (duration of subject enrollment). Count of participants. Unit: Participants

Measure	All Subjects n = 30
Value	30

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from when the subject entered the study to when they completed study procedures. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Interventional Vascular Conditions

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Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
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RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Interventional Vascular Conditions, run by GE Healthcare at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image Guidance Adequacy Collected Via Survey Questionnaire (time frame: Approximately 2 months (duration of subject enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03417713.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.