Performance and Safety Evaluation of an Intradermal Delivery Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359111
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : May 11, 2012
Last Update Posted : May 18, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Injections, Intradermal
Intervention: Device: PATH ID Adapter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Intradermal Adapter Saline injection with intradermal adapter

Participant Flow:   Overall Study
    Intradermal Adapter

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Intradermal Adapter Saline injection with intradermal adapter

Baseline Measures
   Intradermal Adapter 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   20 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 35.4  (9.3) 
[Units: Participants]
Female   8 
Male   12 
Region of Enrollment 
[Units: Participants]
United States   20 

  Outcome Measures

1.  Primary:   Proportion of Injections Delivered to the Intradermal Layer of the Skin   [ Time Frame: 1 day ]

2.  Secondary:   Proportion of Participants With Safety Events   [ Time Frame: 2 days ]

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Courtney Jarrahian
Organization: PATH
phone: 206-285-3500

Responsible Party: PATH Identifier: NCT01359111     History of Changes
Other Study ID Numbers: HS 563
First Submitted: May 2, 2011
First Posted: May 24, 2011
Results First Submitted: April 16, 2012
Results First Posted: May 11, 2012
Last Update Posted: May 18, 2012