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Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01494571
First received: December 12, 2011
Last updated: March 6, 2013
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Functionality and Performance of Device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Completeness of injection [ Time Frame: within one minute after injection ] [ Designated as safety issue: No ]
    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. Measurement of the bleb size following injection will recorded in millimeters.

  • Size of bleb on skin after injection [ Time Frame: within 2 minutes after injection ] [ Designated as safety issue: No ]
    Measurement of the bleb size immediately following injection will be determined using a millimeter ruler

  • Acceptability by subject [ Time Frame: up to 48 hrs ] [ Designated as safety issue: No ]
    subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia.


Enrollment: 101
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
90 pediatric, 7 to 14 year old subjects
30 pediatric, 5 to 6 year old subjects
30 pediatric, 3 to 4 year old subjects
30 pediatric, 1 to 2 year old subjects
30 pediatric, 6 to 12 month old subjects
30 pediatric, 4 to 6 month old subjects
30 pediatric, 2 to 4 month old subjects

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 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.
  Eligibility

Ages Eligible for Study:   2 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Up to 400 children, aged 2 months to 14 years

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494571

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Jeffrey Galinkin, MD Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01494571     History of Changes
Other Study ID Numbers: 11-1362
Study First Received: December 12, 2011
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013