Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum
A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.
1 other identifier
interventional
24
1 country
1
Brief Summary
This study is being done to evaluate intraosseous vascular access through the sternum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedResults Posted
Study results publicly available
October 18, 2013
CompletedDecember 24, 2025
December 1, 2025
1 month
May 9, 2013
June 6, 2013
December 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
during 12 minutes of infusion
Secondary Outcomes (7)
Stability of Locator
During insertion of the intraosseous needle set
Stability of Catheter Hub
During insertion of the intraosseous needle set
Adhesion Strips
During insertion of the intraosseous needle set
Gravity Flow Rates
during the 12 minute infusion time frame
100 Millimeters of Mercury (mmHg) Infusion Flow Rates
during the 12 minute infusion time frame
- +2 more secondary outcomes
Study Arms (1)
Sternal intraosseous vascular access
EXPERIMENTALSternal intraosseous vascular access using T.A.L.O.N. Intraosseous System.
Interventions
intraosseous catheter for use in the sternum
Eligibility Criteria
You may qualify if:
- years of age or older;
- healthy adult subjects
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bulverde-Spring Branch EMS
Spring Branch, Texas, 78070, United States
Results Point of Contact
- Title
- Larry J. Miller, MD
- Organization
- Vidacare Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Larry J Miller, MD
Vidacare Corporation
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 14, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
December 24, 2025
Results First Posted
October 18, 2013
Record last verified: 2025-12