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Performance and Safety Evaluation of an Intradermal Delivery Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:
NCT01359111
First received: May 2, 2011
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.


Condition Intervention Phase
Injections, Intradermal
 Device: PATH ID Adapter
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Performance and Safety Evaluation of an Intradermal Delivery Device

Further study details as provided by Program for Appropriate Technology in Health:

Primary Outcome Measures:
  • Proportion of Injections Delivered to the Intradermal Layer of the Skin [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.


Secondary Outcome Measures:
  • Proportion of Participants With Safety Events [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.

  • Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.


Enrollment: 20
Study Start Date: May 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PATH ID Adapter
    Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female and male participants ages 18 to 55 years.
  • Healthy enough to participate in the clinical trial per site investigator assessment.
  • Healthy skin on the upper deltoid region of both arms.
  • Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
  • Literate in English.
  • Available by telephone 48 hours after the study visit.

Exclusion Criteria:

  • Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
  • Unable to understand the study purpose or procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359111

Locations
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
Program for Appropriate Technology in Health
Investigators
Principal Investigator: Leslie Klaff, MD, PhD Rainier Clinical Research Center
  More Information

No publications provided

Responsible Party: Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier: NCT01359111     History of Changes
Other Study ID Numbers: HS 563
Study First Received: May 2, 2011
Results First Received: April 16, 2012
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Program for Appropriate Technology in Health:
Intradermal injections
Vaccination

ClinicalTrials.gov processed this record on May 19, 2013