CT Scanners X RayNCT01909180
Clinical Evaluation for General Electric (GE) CT System
A study testing Revolution CT Scanner in people with CT Scanners X Ray, run by GE Healthcare at 1 site in United States.
Trial summary
An external evaluation to obtain clinical data to create sample clinical images. The data will also be used for product and technology development, marketing materials, and inclusion in publications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CT Scanners X Ray
- What is being tested?
- Revolution CT Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who voluntarily signed the Informed Consent Form (ICF).
- Male subjects 18 years of age or older.
- Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history.
Who cannot join
- • Subjects previously enrolled in this Evaluation.
- Subjects who are not able or not willing to give written Informed Consent.
- For IV contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma.
- For IV contrast-enhanced CT exams, per the institution's guidelines on risk stratification and prophylaxis for Contrast Induced Neuropathy, subjects will be pre-screened via medical history review by qualified medical personnel for suspected renal function impairment and high risk subjects will undergo a serum creatinine lab test. Any subject with proven renal insufficiency will be excluded.
- Known pregnancy and nursing (lactating) females.
- Any subject with urgent medical condition requiring acute care.
- Any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject.
- Subjects who do not agree to allow GEHC personnel to be present during the scan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baptist South Florida Hospital
Miami, Florida, 33143
About this study
Official title: Clinical Evaluation for GE CT System
An external evaluation to obtain clinical data to create sample clinical images.
The data will also be used for product and technology development, marketing materials, and inclusion in publications.
Read the detailed description
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
- Conditions
- CT Scanners X Ray
- Being tested
- Revolution CT Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revolution CT ScannerDevice
These scans would be considered "standard of care" but, because the subjects are scanned on an uncleared device they are investigational.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac | Experimental | Revolution CT Cardiac Imaging Scan Receives: Device: Revolution CT Scanner |
| Body/Extremity | Experimental | Revolution CT Body and/or Extremity Imaging Scan Receives: Device: Revolution CT Scanner |
| Neuro | Experimental | Revolution CT Brain and Spinal Cord Imaging Scan Receives: Device: Revolution CT Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Image quality assessment on a 5 point Likert Scale:
5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information
1= Non-Diagnostic
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionDec 2013
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 CT Scanners X RayStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Curry, MD, Principal investigator, Baptist South Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909180
- Sponsor's protocol ID
- 106-2011-GES-0003
- Status last verified
- Mar 2016
- First submitted
- 24 Jul 2013
- Last updated
- 22 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation for GE CT System
- ClinicalTrials.gov ID
- NCT01909180
- Acronym / sponsor ID
- 106-2011-GES-0003
- Conditions
- CT Scanners X Ray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An external evaluation to obtain clinical data to create sample clinical images.
The data will also be used for product and technology development, marketing materials, and inclusion in publications.
Detailed description
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac | Experimental | Device: Revolution CT ScannerRevolution CT Cardiac Imaging Scan |
| Body/Extremity | Experimental | Device: Revolution CT ScannerRevolution CT Body and/or Extremity Imaging Scan |
| Neuro | Experimental | Device: Revolution CT ScannerRevolution CT Brain and Spinal Cord Imaging Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who voluntarily signed the Informed Consent Form (ICF).
- Male subjects 18 years of age or older.
- Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history.
Key exclusion criteria (8 listed)
- • Subjects previously enrolled in this Evaluation.
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 |
|---|---|---|
| Revolution CT ScannerThese scans would be considered "standard of care" but, because the subjects are scanned on an uncleared device they are investigational. | Device | Body/Extremity, Cardiac, Neuro |
Primary outcome
Image Quality
Time frame: 24 hours
Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Ricardo Curry, MD principal investigator
Baptist South 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 Revolution CT Scanner in people with CT Scanners X Ray, run by GE Healthcare at 1 site in United States.
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 3 inclusion and 8 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 22 Apr 2016. 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 United States. 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 22 Apr 2016). 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 Quality (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2016.