Status:
COMPLETED
Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
Lead Sponsor:
University of Colorado, Denver
Conditions:
Functionality and Performance of Device
Eligibility:
All Genders
2-14 years
Brief Summary
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
Detailed Description
Up to 400 children, ages 2 months through 14 years 1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter pa...
Eligibility Criteria
Inclusion
- Infants and children between ages 2 months and 14 years
- Outpatient, expected to go home day of surgery
- Written consent and assent when appropriate
- Willing to complete and return pain diary (postcard) after 48 hours
Exclusion
- Presently have skin rash at the intended injection site
- Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
- Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
- Skin disorders that may predispose them to develop skin lesions at sites of trauma.
- Present use of any blood thinning medications.
- In the 10-11 year old cohort, none of the participants can have started puberty.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01494571
Start Date
December 1 2011
End Date
September 1 2012
Last Update
March 7 2013
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045