Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

December 7, 2025 updated by: Vidacare Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Spring Branch, Texas, United States, 78070
        • Bulverde-Spring Branch EMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 21 years of age or older;
  • healthy adult subjects

Exclusion Criteria:

  • 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;
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sternal intraosseous vascular access
Sternal intraosseous vascular access using T.A.L.O.N. Intraosseous System.
Device: T.A.L.O.N. Intraosseous System
intraosseous catheter for use in the sternum
Other Names:
  • EZ-IO TALON

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during 12 minutes of infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stability of Locator
Time Frame: During insertion of the intraosseous needle set

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.
During insertion of the intraosseous needle set
Stability of Catheter Hub
Time Frame: During insertion of the intraosseous needle set
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.
During insertion of the intraosseous needle set
Gravity Flow Rates
Time Frame: during the 12 minute infusion time frame
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).
during the 12 minute infusion time frame
Adhesion Strips
Time Frame: During insertion of the intraosseous needle set
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.
During insertion of the intraosseous needle set
100 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time Frame: during the 12 minute infusion time frame
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.
during the 12 minute infusion time frame
200 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time Frame: during the 12 minute infusion time frame
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.
during the 12 minute infusion time frame
300 Millimeters of Mercury (mmHg) Infusion Flow Rates
Time Frame: during the 12 minute infusion time frame
Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.
during the 12 minute infusion time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vidacare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Larry J Miller, MD, Vidacare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2013

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-04 (Assistance Publique Hôpitaux de Marseille)

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