Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers

Healthy Clinical Trial

Official title:

Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00684333
• Other study ID #: TRC 015/10062
• Status: Suspended
• Phase: N/A
• First received: May 19, 2008
• Last updated: January 10, 2009
• Start date: June 2009
• Est. completion date: February 2010

Study information

• Verified date: January 2009
• Source: Sindolor
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 42
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy Caucasian males and females between 18 and 50 years of age.

• Colour of skin that will enable to clearly observe dermal effects.

• Non-pregnant, non-lactating female subjects whose urine screening pregnancy test is negative.

• Subjects must be available to complete the study.

• Subjects must satisfy a medical examiner about their fitness to participate in the study.

• Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

• Persons with a large amount of hair on the injection sites

• Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions that could interfere with the observation of the injection sites.

• History of skin allergy or hypersensitivity

• History of severe skin infection in the past 1 year.

• History of easy bruising.

• Current or previous history of neurological disorders (particularly neuropathies), low back pain with neurological involvement.

• Any psychological condition that could influence the conduct of the study or interpretation of results.

• A history of drug or alcohol abuse

• Use of alcohol or medications within 48 hours prior to and during study participation

• Any condition, which in the opinion of the Principal Investigator or the study physician would place the subject at risk or influence the conduct of the study or interpretation of results.

• Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• painless subcutaneous injection by EZ-Ject Injector
EZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system

Locations

Country	Name	City	State
Israel	Ichilov Medical center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sindolor

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study primary goal is to evaluate the safety of using the EZ-Ject Injector device for subcutaneous injections.The safety of using the EZ-Ject Injector device will be established by paucity of major complications that are device-related.		immediately	Yes
Secondary	Study secondary goal is to asses the efficacy of using the EZ-Ject Injector device. Efficacy will be assessed by alleviating injection pain. Subjective discomfort and pain will be assessed by analogue pain scale (VAS Scale).		immediately	No