NCT01943110

Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.

A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations

Detailed description

This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years). Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin: * Upper deltoid with the side-load ID adapter * Upper deltoid with the autodisable (AD) ID adapter * Suprascapular (behind the shoulder) with the side-load ID adapter * Suprascapular with the AD ID adapter * Forearm with the side-load ID adapter * Forearm with the AD ID adapter Intradermal administration of each injection will be assessed: * The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded. * The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool. * A photo of the injection site will be taken. Injections will be assessed for safety by observation of injection sites for any local adverse events.

Conditions

• Injections, Intradermal

Interventions

Type	Name	Description
DEVICE	ID adapter (autodisable)	Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
DEVICE	ID adapter (side load)	Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-09-16
• Last updated: 2016-03-02
• Results posted: 2015-06-19

Locations

1 site across 1 country: United States