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

Sponsored by:	Sindolor
Information provided by:	Sindolor
ClinicalTrials.gov Identifier:	NCT00684333

Purpose

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.

Condition	Intervention
Healthy	Device: painless subcutaneous injection by EZ-Ject Injector

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers

Further study details as provided by Sindolor:

Primary Outcome Measures:

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. [ Time Frame: immediately ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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). [ Time Frame: immediately ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	June 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group 1: Experimental volunteers	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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684333

Locations

Israel
Ichilov Medical center
Tel-Aviv, Israel

Sponsors and Collaborators

Sindolor

Investigators

Principal Investigator:

Jacob Atsmon, M.D.

Ichilov Medical center

More Information

Responsible Party:	Sindolor ( Dr. Hanna Levy )
Study ID Numbers:	TRC 015/10062
Study First Received:	May 19, 2008
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00684333
Health Authority:	Israel: Ministry of Health

Keywords provided by Sindolor:

painless Injections
Subcutaneous Injections
Subcutaneous Injections to healthy volunteers

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on January 16, 2009