Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System (PharmaJet)

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.

Study Overview

• Status: Completed
• Conditions: Functionality and Performance of Device

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.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 400 children, aged 2 months to 14 years

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of injection	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.	within one minute after injection
Size of bleb on skin after injection	Measurement of the bleb size immediately following injection will be determined using a millimeter ruler	within 2 minutes after injection
Acceptability by subject	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.	up to 48 hrs

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jeffrey Galinkin, MD, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: December 15, 2011
• First Posted (Estimate): December 19, 2011

Study Record Updates

• Last Update Posted (Estimate): March 7, 2013
• Last Update Submitted That Met QC Criteria: March 6, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 11-1362

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No