Intraosseous Vascular AccessNCT01853215
Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
A study testing T.A.L.O.N. Intraosseous System in people with Intraosseous Vascular Access, run by Vidacare Corporation at 1 site in United States.
Trial summary
This study is being done to evaluate intraosseous vascular access through the sternum. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraosseous Vascular Access
- What is being tested?
- T.A.L.O.N. Intraosseous System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older;
- healthy adult subjects
Who cannot join
- Weight < 45kg;
- BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
- Imprisoned subjects;
- pregnant subjects;
- prior sternotomy;
- cognitively impaired subjects;
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- 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 48 hours or other significant orthopedic procedure in target bone;
- current use of anti-coagulants;
- previous adverse reaction to Lidocaine;
- current cardiac condition requiring pacemaker or anti-arrhythmic drugs
- previous adverse reaction to contrast dye
- Allergy to any food and drug
- History of impaired renal function
- History of impaired hepatic function
- History of cardiac disease
- History of pheochromocytoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Bulverde-Spring Branch EMS
Spring Branch, Texas, 78070
About this study
Official title: A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
This study is being done to evaluate intraosseous vascular access through the sternum.
Read the detailed description
The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.
- Conditions
- Intraosseous Vascular Access
- Being tested
- T.A.L.O.N. Intraosseous System
- Keywords
- sternal intraosseous infusion study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T.A.L.O.N. Intraosseous SystemDevice
Also called EZ-IO TALON
intraosseous catheter for use in the sternum
| Study group | Role | What they receive |
|---|---|---|
| Sternal intraosseous vascular access | Experimental | Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System. Receives: Device: T.A.L.O.N. Intraosseous System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of Extravasation During Infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
Measured: during 12 minutes of infusion
Secondary outcomes (7)
Stability of Locator
Operator's perceived stability of the sternal locator once placed on the subject.
1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent.
Measured: During insertion of the intraosseous needle set
Stability of Catheter Hub
Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.
Measured: During insertion of the intraosseous needle set
Adhesion Strips
Perceived effectiveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent.
Measured: During insertion of the intraosseous needle set
Gravity Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).
Measured: during the 12 minute infusion time frame
100 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.
Measured: during the 12 minute infusion time frame
200 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.
Measured: during the 12 minute infusion time frame
300 Millimeters of Mercury (mmHg) Infusion Flow Rates
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.
Measured: during the 12 minute infusion time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionMay 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 Intraosseous Vascular AccessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry J Miller, MD, Principal investigator, Vidacare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853215
- Sponsor's protocol ID
- 2013-04
- Status last verified
- Dec 2025
- First submitted
- 9 May 2013
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
- ClinicalTrials.gov ID
- NCT01853215
- Acronym / sponsor ID
- 2013-04
- Conditions
- Intraosseous Vascular Access
- Keywords
- sternal intraosseous infusion study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 18 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to evaluate intraosseous vascular access through the sternum.
Detailed description
The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sternal intraosseous vascular access | Experimental | Device: T.A.L.O.N. Intraosseous SystemSternal intraosseous vascular access using T.A.L.O.N. Intraosseous System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 21 years of age or older;
- healthy adult subjects
Key exclusion criteria (19 listed)
- Weight < 45kg;
- BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
- Imprisoned subjects;
- pregnant subjects;
- prior sternotomy;
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 |
|---|---|---|
| T.A.L.O.N. Intraosseous SystemAlso: EZ-IO TALONintraosseous catheter for use in the sternum | Device | Sternal intraosseous vascular access |
Primary outcome
Occurrences of Extravasation During Infusion
Time frame: during 12 minutes of infusion
The number of participants with occurrence of extravasation during intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.
7 secondary outcomes
Stability of Locator
Time frame: During insertion of the intraosseous needle set
Stability of Catheter Hub
Time frame: During insertion of the intraosseous needle set
Adhesion Strips
Time frame: During insertion of the intraosseous needle set
Gravity Flow Rates
Time frame: during the 12 minute infusion time frame
100 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time frame: during the 12 minute infusion time frame
200 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time frame: during the 12 minute infusion time frame
300 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time frame: during the 12 minute infusion time frame
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Larry J Miller, MD principal investigator
Vidacare Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T.A.L.O.N. Intraosseous System in people with Intraosseous Vascular Access, run by Vidacare Corporation 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 2 inclusion and 19 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 24 Dec 2025. 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 Oct 2013). 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?
Occurrences of Extravasation During Infusion (time frame: during 12 minutes of infusion). 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 24 Dec 2025.