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

January 10, 2009 updated by: Sindolor

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Ichilov Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
immediately

Secondary Outcome Measures

Outcome Measure
Time Frame
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
immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sindolor

Investigators

  • Principal Investigator: Jacob Atsmon, M.D., Ichilov Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

February 1, 2010

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 10, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRC 015/10062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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