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
Results First Received: April 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Injections, Intradermal
Intervention: Device: PATH ID Adapter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intradermal Adapter Saline injection with intradermal adapter

Participant Flow:   Overall Study
    Intradermal Adapter  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Intradermal Adapter Saline injection with intradermal adapter

Baseline Measures
    Intradermal Adapter  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.4  ± 9.3  
Gender  
[units: participants]
 
Female     8  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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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


  More Information
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Courtney Jarrahian
Organization: PATH
phone: 206-285-3500
e-mail: cjarrahian@path.org


No publications provided


Responsible Party: PATH
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