HealthyNCT02337959
Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors
A study testing Radiation in people with Healthy, run by Carestream Health, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- X-ray images of nearly identical positioning and exposure
- No visible image artifacts
- Subject 21years or older
- Subject has provided informed consent
- Subject is in good general health
- Subject is able to stand for two (2) x-rays
Who cannot join
- Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
- Subject is pregnant or suspicious of being pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
- Has undergone radiation therapy
- Has had two (2) or more CT scans within the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester
Rochester, New York, 14642-8648
About this study
The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Read the detailed description
The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) ("investigational device") as compared to the currently marketed Carestream DRX-1 Detector ("predicate device"). The evaluation will consist primarily of comparing the diagnostic image quality of double-imaged pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique for similar detector types (i.e. comparing DRX-1 GOS predicate with DRX Plus GOS) or exposure adjusted technique when different detector types are compared.
Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.
The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken. The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.
If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.
Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector.
All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
| Study group | Role | What they receive |
|---|---|---|
| Predicate & Invest.-GOS | Experimental | Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. Receives: Radiation: Radiation |
| Predicate & Invest.-CsI | Experimental | Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. Receives: Radiation: Radiation |
| Predicate & Invest.-Cadavers GOS & CsI | Experimental | Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detectors. Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radlex Scale for Diagnostic Capability Ratings
1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Measured: 9 weeks after last x-ray capture
Secondary outcomes (1)
Pair Preference Rating
During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.
Measured: 9 weeks after last x-ray capture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionMar 2015
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 HealthyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carestream Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hobbs, MD, Principal investigator, University of RochesterSteven Don, MD, Principal investigator, St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337959
- Sponsor's protocol ID
- 6K9740
- Status last verified
- Jun 2015
- First submitted
- 2 Jan 2015
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors
- ClinicalTrials.gov ID
- NCT02337959
- Acronym / sponsor ID
- 6K9740
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Carestream Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Posted 18 Apr 2016
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 this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Detailed description
The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) ("investigational device") as compared to the currently marketed Carestream DRX-1 Detector ("predicate device"). The evaluation will consist primarily of comparing the diagnostic image quality of double-imaged pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique for similar detector types (i.e. comparing DRX-1 GOS predicate with DRX Plus GOS) or exposure adjusted technique when different detector types are compared.
Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.
The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken. The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.
If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.
Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector.
All subjects are healthy volunteers recruited by flyer. All subjects will be imaged with the same predicate detector and one (1) of the investigational detectors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Predicate & Invest.-GOS | Experimental | Radiation: RadiationRadiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector. |
| Predicate & Invest.-CsI | Experimental | Radiation: RadiationRadiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector. |
| Predicate & Invest.-Cadavers GOS & CsI | Experimental | Radiation: RadiationRadiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detectors. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- X-ray images of nearly identical positioning and exposure
- No visible image artifacts
- Subject 21years or older
- Subject has provided informed consent
- Subject is in good general health
Key exclusion criteria (7 listed)
- Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
- Subject is pregnant or suspicious of being pregnant
- Not able or willing to provide Informed Consent, or consent is withdrawn
- Not able to collect all required case information
- Subject has a history of high radiation exposure:
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 |
|---|---|---|
| RadiationLive subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors. | Radiation | Predicate & Invest.-Cadavers GOS & CsI, Predicate & Invest.-CsI, Predicate & Invest.-GOS |
Primary outcome
Radlex Scale for Diagnostic Capability Ratings
Time frame: 9 weeks after last x-ray capture
1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
1 secondary outcome
Pair Preference Rating
Time frame: 9 weeks after last x-ray capture
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Susan Hobbs, MD principal investigator
University of Rochester
Steven Don, MD principal investigator
St. Louis Children's 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 Radiation in people with Healthy, run by Carestream Health, Inc. 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 6 inclusion and 7 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 18 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 18 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?
Radlex Scale for Diagnostic Capability Ratings (time frame: 9 weeks after last x-ray capture). 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 18 Apr 2016.