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Performance and Safety Evaluation of an Intradermal Delivery Device

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ClinicalTrials.gov Identifier: NCT01359111
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : May 11, 2012
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
PATH

Brief Summary:
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 or disease Intervention/treatment Phase
Injections, Intradermal Device: PATH ID Adapter Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Performance and Safety Evaluation of an Intradermal Delivery Device
Study Start Date : May 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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.


Primary Outcome Measures :
  1. Proportion of Injections Delivered to the Intradermal Layer of the Skin [ Time Frame: 1 day ]
    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 :
  1. Proportion of Participants With Safety Events [ Time Frame: 2 days ]
    The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.

  2. Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin. [ Time Frame: 1 day ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359111


Locations
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Leslie Klaff, MD, PhD Rainier Clinical Research Center

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01359111     History of Changes
Other Study ID Numbers: HS 563
First Posted: May 24, 2011    Key Record Dates
Results First Posted: May 11, 2012
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by PATH:
Intradermal injections
Vaccination