Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) ExamNCT01531686
Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route
An observational study of Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam, run by Vidacare Corporation at 4 sites in United States.
Trial summary
An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam
- What is being tested?
- Intraosseous delivery of CT contrast dye
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2012to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who have received proximal humerus intraosseous vascular access as standard of care via the EZ-IO 45 mm needle set and require Computed Tomography (CT) examination
Who may be able to join
- Aged 18 years or older
- Has received intraosseous (IO) vascular access at the proximal humerus insertion site via EZ-IO 45 mm needle set, as standard of care
- Requires Computed Tomography (CT) examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
- Cognitively and physically able to give written consent to participate in the study or is obtained from a Legally Authorized Representative (LAR)
Who cannot join
- Fracture in target bone, or significant trauma to the site
- Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- Infection in target area
- IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
- Allergy to contrast media
- Imprisoned
Show all 10Show fewer
- Pregnant
- Requires English language translation other than Spanish
- Has received proximal humerus IO access with an IO catheter other than the EZ-IO 45 millimeter (mm) needle set system
- Has existing proximal humerus IO access using the EZ-IO 45 mm needle set but IO catheter is mal-positioned or dislodged
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Shands Critical Care Center and Cancer Hospital
Gainesville, Florida, 32608
Grand Strand Regional Medical
Myrtle Beach, South Carolina, 29572
Maricopa Medical Center
Phoenix, Arizona, 85008
Olive View UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination.
Read the detailed description
An observational study to determine the safety and effectiveness of Proximal Humerus Intraosseous (IO) vascular access for delivery of contrast medium for Computed Tomography (CT) examination. The hypothesis is that Proximal Humerus IO access in conjunction with a pressure-limited power injection device can be safely and effectively used to deliver contrast medium for CT examination.
- Being tested
- Intraosseous delivery of CT contrast dye
- Keywords
- intraosseous vascular access, Computed Tomography (CT) examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous delivery of CT contrast dyeProcedure or surgery
Also called EZ-IO
Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of Computed Tomography (CT) Image
Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination.
Measured: at time of CT examination average time is within 24 hours
Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination
incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination
Measured: at time of CT examination average time is within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Slow rate of enrollment
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 Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) ExamStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Philbeck, PhD, Study director, Sponsor Company- Vidacare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531686
- Sponsor's protocol ID
- 2011-02
- Status last verified
- Dec 2016
- First submitted
- 3 Feb 2012
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
- ClinicalTrials.gov ID
- NCT01531686
- Acronym / sponsor ID
- 2011-02
- Keywords
- intraosseous vascular access, Computed Tomography (CT) examination
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow rate of enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination.
Detailed description
An observational study to determine the safety and effectiveness of Proximal Humerus Intraosseous (IO) vascular access for delivery of contrast medium for Computed Tomography (CT) examination. The hypothesis is that Proximal Humerus IO access in conjunction with a pressure-limited power injection device can be safely and effectively used to deliver contrast medium for CT examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have received proximal humerus intraosseous vascular access as standard of care via the EZ-IO 45 mm needle set and require Computed Tomography (CT) examination
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Has received intraosseous (IO) vascular access at the proximal humerus insertion site via EZ-IO 45 mm needle set, as standard of care
- Requires Computed Tomography (CT) examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
- Cognitively and physically able to give written consent to participate in the study or is obtained from a Legally Authorized Representative (LAR)
Key exclusion criteria (10 listed)
- Fracture in target bone, or significant trauma to the site
- Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- Infection in target area
- IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
- Allergy to contrast media
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 |
|---|---|---|
| Intraosseous delivery of CT contrast dyeAlso: EZ-IODelivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination. | Procedure or surgery | – |
Primary outcome
Adequacy of Computed Tomography (CT) Image
Time frame: at time of CT examination average time is within 24 hours
Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination.
Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination
Time frame: at time of CT examination average time is within 30 minutes
incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Thomas Philbeck, PhD study director
Sponsor Company- Vidacare Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam, run by Vidacare Corporation at 4 sites 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 4 inclusion and 10 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 11 Feb 2026). 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?
Adequacy of Computed Tomography (CT) Image (time frame: at time of CT examination average time is within 24 hours). The study lists 2 primary outcomes in all. 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 11 Feb 2026.