Clinical trial NCT00684333: Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Official title: Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Healthy
Keywords: painless Injections
Subcutaneous Injections
Subcutaneous Injections to healthy volunteers
Lead sponsor: Sindolor
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: immediately
Secondary outcomes:
measure: 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).
timeFrame: immediately
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Ichilov Medical center
Study officials:
affiliation: Ichilov Medical center
name: Jacob Atsmon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: