Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219453
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-09-13
Brief Title:
Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination
Sponsor:
PATH
Organization:
PATH
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine the ability of the Protector Cap Jet Injector to prevent cross-contamination in the next injection sample The hypothesis is that the Protector Cap Jet Injector will prevent contamination in the next injection sample even following injection of volunteers with high levels of hepatitis B virus
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None