Contrast Enhanced Computed TomographyARCTR05NCT01772550
Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
A study testing 20GA BD Nexiva Diffusics and 18GA Conventional Catheter in people with Contrast Enhanced Computed Tomography, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
The purpose of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Enhanced Computed Tomography
- What is being tested?
- 20GA BD Nexiva Diffusics and 18GA Conventional Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years old at the time of enrollment,
- Must meet the investigational site's standard criteria for multi-detector Computed Tomography (CT),
- Per institutional protocol, the ordered scan must require a flow rate of 5.0-7.0 mL/sec (inclusive) for Visipaque 320 or 5.0-7.5 mL/sec (inclusive) for Omnipaque350 warmed to 35°C,
- The planned catheter insertion site must be located in the antecubital area,
- Must require any of the following multi-detector CT procedures: CT angiogram,CT pancreas,CT liver, CT kidney, Cardiac CT,
- Must be willing and able to provide informed consent,
- Must be able to read, write, and follow instructions in English,
- Must be able to accommodate a 20 G x 1.00 inch IV catheter,
Who cannot join
- Preexisting IV catheter or contrast-compatible port in place suitable for power injection with the intent to be used for contrast enhanced CT,
- Subjects who have reported an adverse reaction that precludes use of iodine-based contrast media,
- Subjects who have had a prior extravasation event involving solutions considered irritants or vesicants.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: A Randomized Controlled Study to Determine Whether Smaller Gauge Fenestrated Catheters Are as Effective as Larger Gauge Non-fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
The purpose of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter.
In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly deliver contrast agent to an individual's circulatory system. The contrast allows for greater differentiation of tissues in images of the area of interest, affording a better opportunity to visually assess the area and hence make a more accurate diagnosis.
CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is required to achieve these high flow rates; however, often the patient does not have a vein that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is designed to deliver a higher flow rate than a conventional catheter of the same gauge by incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to exit the catheter in addition to that which normally exits through the main opening at the tip of the catheter.
Read the detailed description
This is a prospective study performed in adult human subjects who have been referred for a CECT. The study will occur during a single visit. Once consented and enrolled, subjects whose antecubital veins can accommodate an 18 GA IV catheter (as assessed by the Inserter or designee of the PI), will be randomized to receive either a conventional 18 GA IV catheter (reference, control) or a 20 GA BD Nexiva™ Diffusics™ IV catheter (test). Subjects whose veins are not considered suitable for an 18 GA IV catheter will be placed in a non-randomized cohort for placement of a 20 GA BD Nexiva™ Diffusics™ IV catheter. Subjects will receive one (1) catheter for the study.
The primary objective of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 GA fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter. The 20 GA BD Nexiva™ Diffusics™ IV catheter will be considered non-inferior to conventional 18 GA IV catheters if the 95% upper bound for the difference in percentage of images of acceptable quality between the images acquired using the 18 GA IV catheters and the 20 GA BD Nexiva™ Diffusics™ IV catheters is less than 15%.
Study catheters will be inserted by appropriately licensed healthcare professionals (Inserters). Prior to enrollment, potential Inserters will be trained and qualified by the Sponsor on proper use of the BD Nexiva™ Diffusics™ IV catheter in both an artificial hand model and then in human patients. Inserters will then be expected to use the test product for a period of two (2) weeks, in order to gain familiarity with the product. Because BD Nexiva™ Diffusics™ IV catheters are not currently used in the Johns Hopkins Outpatient Center, the Sponsor will provide BD Nexiva™ Diffusics™ IV catheters for use during this training and familiarization period.
- Conditions
- Contrast Enhanced Computed Tomography
- Being tested
- 20GA BD Nexiva Diffusics, 18GA Conventional Catheter
- Keywords
- CECT, catheter, contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20GA BD Nexiva DiffusicsDevice
Also called 20G x 1 inch BD Nexiva™ Diffusics™ IV catheter (#383592)
The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.
If the Inserter is unsuccessful in the second attempt, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.
18GA Conventional CatheterDevice
Also called 18G x 1.25 inch Smiths Medical Jelco® IV Catheter (cat#4055)
The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.
If after the first attempt, there is no vein in the contralateral arm that can accommodate an 18 gauge catheter, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.
| Study group | Role | What they receive |
|---|---|---|
| 20 Gauge BD Nexiva Diffusics | Experimental | During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch). Receives: Device: 20GA BD Nexiva Diffusics |
| 18 Gauge Conventional Catheter | Active comparator | During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the non-fenestrated 18GA Conventional Catheter (18 GA x 1.25 inch Smiths Medical Jelco® IV Catheter). Receives: Device: 18GA Conventional Catheter |
| BD Nexiva Diffusics - Nonrandomized | Experimental | Subjects whose veins were not suitable for an 18 GA IV Catheter were assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch) Receives: Device: 20GA BD Nexiva Diffusics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable Image Quality
Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:
- The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,
- the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.
In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority.
Measured: at the time of image assessment
Secondary outcomes (11)
Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects
Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.
Measured: at the time of image assessment
Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.
Measured: at the time of image assessment
Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.
Measured: at the time of image assessment
Maximum Flow Rate
Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.
Measured: immediately after power injection
Catheter Insertion Success
Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.
The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study.
Measured: immediately after catheter insertion
Extravasation of Contrast Media
The number of subjects who experienced injections with extravasation of contrast media is reported.
Measured: upon contrast injection
Automatic Injection Shutoff
The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.
Measured: immediately after contrast injection
High Pressure Alarm
The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.
Measured: immediately after contrast injection
Catheter Dislodgement
The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.
Measured: Immediately following power injection
Catheter Transfixation
The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.
Measured: immediately after power injection
Catheter Integrity Failure
Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.
The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.
Measured: immediately after power injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 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 Contrast Enhanced Computed TomographyStudies 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
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elliot Fishman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772550
- Sponsor's protocol ID
- INF-11-ARCTR05
- Acronym
- ARCTR05
- Status last verified
- Apr 2014
- First submitted
- 17 Jan 2013
- Last updated
- 2 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Determine Whether Smaller Gauge Fenestrated Catheters Are as Effective as Larger Gauge Non-fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
- ClinicalTrials.gov ID
- NCT01772550
- Acronym / sponsor ID
- ARCTR05 / INF-11-ARCTR05
- Conditions
- Contrast Enhanced Computed Tomography
- Keywords
- CECT, catheter, contrast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Posted 26 Mar 2014
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 study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter.
In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly deliver contrast agent to an individual's circulatory system. The contrast allows for greater differentiation of tissues in images of the area of interest, affording a better opportunity to visually assess the area and hence make a more accurate diagnosis.
CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is required to achieve these high flow rates; however, often the patient does not have a vein that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is designed to deliver a higher flow rate than a conventional catheter of the same gauge by incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to exit the catheter in addition to that which normally exits through the main opening at the tip of the catheter.
Detailed description
This is a prospective study performed in adult human subjects who have been referred for a CECT. The study will occur during a single visit. Once consented and enrolled, subjects whose antecubital veins can accommodate an 18 GA IV catheter (as assessed by the Inserter or designee of the PI), will be randomized to receive either a conventional 18 GA IV catheter (reference, control) or a 20 GA BD Nexiva™ Diffusics™ IV catheter (test). Subjects whose veins are not considered suitable for an 18 GA IV catheter will be placed in a non-randomized cohort for placement of a 20 GA BD Nexiva™ Diffusics™ IV catheter. Subjects will receive one (1) catheter for the study.
The primary objective of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 GA fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter. The 20 GA BD Nexiva™ Diffusics™ IV catheter will be considered non-inferior to conventional 18 GA IV catheters if the 95% upper bound for the difference in percentage of images of acceptable quality between the images acquired using the 18 GA IV catheters and the 20 GA BD Nexiva™ Diffusics™ IV catheters is less than 15%.
Study catheters will be inserted by appropriately licensed healthcare professionals (Inserters). Prior to enrollment, potential Inserters will be trained and qualified by the Sponsor on proper use of the BD Nexiva™ Diffusics™ IV catheter in both an artificial hand model and then in human patients. Inserters will then be expected to use the test product for a period of two (2) weeks, in order to gain familiarity with the product. Because BD Nexiva™ Diffusics™ IV catheters are not currently used in the Johns Hopkins Outpatient Center, the Sponsor will provide BD Nexiva™ Diffusics™ IV catheters for use during this training and familiarization period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 Gauge BD Nexiva Diffusics | Experimental | Device: 20GA BD Nexiva DiffusicsDuring their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch). |
| 18 Gauge Conventional Catheter | Active comparator | Device: 18GA Conventional CatheterDuring their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the non-fenestrated 18GA Conventional Catheter (18 GA x 1.25 inch Smiths Medical Jelco® IV Catheter). |
| BD Nexiva Diffusics - Nonrandomized | Experimental | Device: 20GA BD Nexiva DiffusicsSubjects whose veins were not suitable for an 18 GA IV Catheter were assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be at least 18 years old at the time of enrollment,
- Must meet the investigational site's standard criteria for multi-detector Computed Tomography (CT),
- Per institutional protocol, the ordered scan must require a flow rate of 5.0-7.0 mL/sec (inclusive) for Visipaque 320 or 5.0-7.5 mL/sec (inclusive) for Omnipaque350 warmed to 35°C,
- The planned catheter insertion site must be located in the antecubital area,
- Must require any of the following multi-detector CT procedures: CT angiogram,CT pancreas,CT liver, CT kidney, Cardiac CT,
Key exclusion criteria (3 listed)
- Preexisting IV catheter or contrast-compatible port in place suitable for power injection with the intent to be used for contrast enhanced CT,
- Subjects who have reported an adverse reaction that precludes use of iodine-based contrast media,
- Subjects who have had a prior extravasation event involving solutions considered irritants or vesicants.
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 |
|---|---|---|
| 20GA BD Nexiva DiffusicsAlso: 20G x 1 inch BD Nexiva™ Diffusics™ IV catheter (#383592)The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm. If the Inserter is unsuccessful in the second attempt, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies. | Device | 20 Gauge BD Nexiva Diffusics, BD Nexiva Diffusics - Nonrandomized |
| 18GA Conventional CatheterAlso: 18G x 1.25 inch Smiths Medical Jelco® IV Catheter (cat#4055)The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm. If after the first attempt, there is no vein in the contralateral arm that can accommodate an 18 gauge catheter, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies. | Device | 18 Gauge Conventional Catheter |
Primary outcome
Acceptable Image Quality
Time frame: at the time of image assessment
Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by: * The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and, * the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type. In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority.
11 secondary outcomes
Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects
Time frame: at the time of image assessment
Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
Time frame: at the time of image assessment
Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
Time frame: at the time of image assessment
Maximum Flow Rate
Time frame: immediately after power injection
Catheter Insertion Success
Time frame: immediately after catheter insertion
Extravasation of Contrast Media
Time frame: upon contrast injection
Automatic Injection Shutoff
Time frame: immediately after contrast injection
High Pressure Alarm
Time frame: immediately after contrast injection
Catheter Dislodgement
Time frame: Immediately following power injection
Catheter Transfixation
Time frame: immediately after power injection
Catheter Integrity Failure
Time frame: immediately after power injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elliot Fishman, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20GA BD Nexiva Diffusics and 18GA Conventional Catheter in people with Contrast Enhanced Computed Tomography, run by Becton, Dickinson and Company 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 8 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 2 May 2014. 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 26 Mar 2014). 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?
Acceptable Image Quality (time frame: at the time of image assessment). 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 2 May 2014.