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

NCT ID: NCT00684333

Last Updated: 2009-01-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-02-28

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

group 1

volunteers

Group Type: EXPERIMENTAL

painless subcutaneous injection by EZ-Ject Injector

Intervention Type: DEVICE

EZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system

Interventions

painless subcutaneous injection by EZ-Ject Injector

EZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sindolor

INDUSTRY

Sponsor Role: lead

Responsible Party

Sindolor

Principal Investigators

Jacob Atsmon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ichilov Medical center

Locations

Ichilov Medical center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

TRC 015/10062

Identifier Type: -

Identifier Source: org_study_id