Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

prior sternotomy;
current cardiac condition requiring pacemaker or anti-arrhythmic drugs
infection in target area;
...
prior sternotomy;
current cardiac condition requiring pacemaker or anti-arrhythmic drugs
infection in target area;
Weight < 45kg;
pregnant subjects;
Allergy to any food and drug
IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
History of pheochromocytoma
History of impaired hepatic function
previous adverse reaction to Lidocaine;
current use of anti-coagulants;
Imprisoned subjects;
BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
previous adverse reaction to contrast dye
fracture in target bone, or significant trauma to the site;
excessive tissue and/or absence of adequate anatomical landmarks in target bone;
History of impaired renal function
History of cardiac disease
cognitively impaired subjects;

Summary

Conditions
Intraosseous Vascular Access
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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...

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.

Inclusion Criterias

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

Exclusion Criterias

prior sternotomy;
current cardiac condition requiring pacemaker or anti-arrhythmic drugs
infection in target area;
...
prior sternotomy;
current cardiac condition requiring pacemaker or anti-arrhythmic drugs
infection in target area;
Weight < 45kg;
pregnant subjects;
Allergy to any food and drug
IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
History of pheochromocytoma
History of impaired hepatic function
previous adverse reaction to Lidocaine;
current use of anti-coagulants;
Imprisoned subjects;
BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
previous adverse reaction to contrast dye
fracture in target bone, or significant trauma to the site;
excessive tissue and/or absence of adequate anatomical landmarks in target bone;
History of impaired renal function
History of cardiac disease
cognitively impaired subjects;

Locations

Spring Branch, Texas, 78070
Spring Branch, Texas, 78070

Tracking Information

NCT #
NCT01853215
Collaborators
Not Provided
Investigators
  • Principal Investigator: Larry J Miller, MD Vidacare Corporation
  • Larry J Miller, MD Vidacare Corporation