Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
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|ClinicalTrials.gov Identifier: NCT00219453|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Virus Diseases Hepatitis B||Device: Jet Injector with Protector Cap (HSI-500)||Phase 1|
The jet injector is a needle-free injection device that uses a high-pressure stream to penetrate the skin and deliver medication into intradermal, subcutaneous, or intramuscular tissues. Multi-dose jet injectors are a type of jet injector with a reusable fluid path that consists of the vial adapter, dose chamber, fluid pathway, and nozzle. Although credited with decades of use and the delivery of millions of doses of vaccine in the field, multi-dose jet injectors are no longer used due to evidence of cross-contamination between injections. The HSI-500 Jet Injector with Protector Cap has been designed with a disposable plastic cap that acts as a shield between the nozzle and the skin to eliminate cross-contamination between injections while maintaining a high rate of vaccine delivery to multiple patients.
The objective of this pilot safety study is to provide a preliminary indication of the ability of the jet injector to prevent cross-contamination from hepatitis B virus between volunteer injections. A secondary objective of the study is to test study procedures prior to a larger-scale safety study.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Safety Study to Determine the Presence of Hepatitis B Virus in Downstream Injection Samples Using the HSI-500 Jet Injector With Protector Cap|
|Study Start Date :||October 2004|
|Study Completion Date :||January 2006|
- Presence of hepatitis B virus in post-injection saline samples as verified by a polymerase chain reaction (PCR)-based assay
- Evaluation of injection site reactions by observation and self-report of pain on a scale (none, mild, moderate, severe)
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): NCT00219453
|Study Director:||Darin L Zehrung, BS||PATH|