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
|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)|
|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|
- 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.
- 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.
- 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.
- 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.
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
|United States, Washington|
|Rainier Clinical Research Center|
|Renton, Washington, United States, 98057|
|Principal Investigator:||Leslie Klaff, MD, PhD||Rainier Clinical Research Center|