Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-31 @ 1:00 PM
Study NCT ID:
NCT00684333
Status:
SUSPENDED
Last Update Posted:
2009-01-14
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Sponsor:
Sindolor
Organization:
Study Overview
Official Title:
Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Status:
SUSPENDED
Status Verified Date:
2009-01
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:
Subcutaneous injections are a widely used method for drug delivery. One of its major drawbacks is the pain inflicted during the process. Sindolor has developed the chemical-free EZ-Ject Injector device, based on employing cutaneous local anesthesia on the injection site by an electronic anesthetic system. The purpose of this study is to determine the safety and efficacy of the EZ-Ject for subcutaneous injections.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: