Interventional Vascular ConditionsNCT03096483

Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System

A study testing OEC Elite system in people with Interventional Vascular Conditions, run by GE Healthcare at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Interventional Vascular Conditions
What is being tested?: OEC Elite system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteCanada
Study dates: 19 Jun 2017to 7 Jul 2017
Phase: Interventional
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old);
Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed;
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

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.

Read the 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.

Conditions: Interventional Vascular Conditions
Being tested: OEC Elite system

What participants receive

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

OEC Elite systemDevice
Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures

Study groups in NCT03096483
Study group	Role	What they receive
OEC Elite Imaging Arm	Experimental	Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system Receives: Device: OEC Elite system

What is being measured

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

Imaging Guidance Adequacy Assessed by Number of Questionnaires
Per-subject investigator report for procedure completion using the Investigational Device
Measured: 2 Months

Secondary outcomes (1)

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
Measured: 2 months

Timeline

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

19 Jun 20177 Jul 2017

First posted30 Mar 2017
Study start19 Jun 2017
Primary completion7 Jul 2017
Study completion7 Jul 2017

Why it stopped: Sponsor determination

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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03096483
Sponsor's protocol ID: 104-2016-PTHS-0005
Status last verified: Mar 2019
First submitted: 16 Mar 2017
Last updated: 27 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System
ClinicalTrials.gov ID: NCT03096483
Acronym / sponsor ID: 104-2016-PTHS-0005
Conditions: Interventional Vascular Conditions
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor determination
Enrolment: 12 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 19 Jun 2017 (actual)
Primary completion: 7 Jul 2017 (actual)
Study completion: 7 Jul 2017 (actual)
First posted: 30 Mar 2017 (actual)
Results: Posted 27 Mar 2019

Clinical summary

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

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OEC Elite Imaging Arm	Experimental	Device: OEC Elite systemVascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old);
Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed;
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
OEC Elite systemAdults undergoing vascular, gastrointestinal (GI), urology or pain management procedures	Device	OEC Elite Imaging Arm

Primary outcome

Imaging Guidance Adequacy Assessed by Number of Questionnaires
Time frame: 2 Months
Per-subject investigator report for procedure completion using the Investigational Device

1 secondary outcome

Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
Time frame: 2 months

Results and safety

Results posted to the registry on 27 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OEC Elite Imaging Arm	12	11

Primary outcome: Imaging Guidance Adequacy Assessed by Number of Questionnaires

Time frame: 2 Months. Number. Unit: Image Guidance Adequacy Questionnaire

Measure	OEC Elite Imaging Arm n = 11
Value	11

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: On a per-subject basis, from the point of enrollment to end of study procedure (i.e. approximately 0.5 days per subject).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OEC Elite Imaging Arm	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Interventional Vascular Conditions

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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.

Theodore Rapanos principal investigator

Hamilton General Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing OEC Elite system in people with 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: stopped early, as of the sponsor's last update on 27 Mar 2019. 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 27 Mar 2019). 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?

Imaging Guidance Adequacy Assessed by Number of Questionnaires (time frame: 2 Months). 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 NCT03096483.

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 27 Mar 2019.