Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
NCT ID: NCT01494571
Last Updated: 2013-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2011-12-31
2012-09-30
Brief Summary
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Detailed Description
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1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
2. To document completeness of injections; completeness is defined as \<10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
3. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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90 pediatric, 7 to 14 year old subjects
No interventions assigned to this group
30 pediatric, 5 to 6 year old subjects
No interventions assigned to this group
30 pediatric, 3 to 4 year old subjects
No interventions assigned to this group
30 pediatric, 1 to 2 year old subjects
No interventions assigned to this group
30 pediatric, 6 to 12 month old subjects
No interventions assigned to this group
30 pediatric, 4 to 6 month old subjects
No interventions assigned to this group
30 pediatric, 2 to 4 month old subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
2 Months
14 Years
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Galinkin, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Other Identifiers
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11-1362
Identifier Type: -
Identifier Source: org_study_id
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