Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Performance and Safety Evaluation of an Intradermal Delivery Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01359111
First received: May 2, 2011
Last updated: May 10, 2012
Last verified: May 2012

May 2, 2011
May 10, 2012
May 2011
May 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01359111 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Performance and Safety Evaluation of an Intradermal Delivery Device
Phase I Performance and Safety Evaluation of an Intradermal Delivery Device

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Injections, Intradermal
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01359111
HS 563
No
PATH
PATH
Not Provided
Principal Investigator: Leslie Klaff, MD, PhD Rainier Clinical Research Center
PATH
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP