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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Sindolor
ClinicalTrials.gov Identifier:
NCT00684333
First received: May 19, 2008
Last updated: January 10, 2009
Last verified: January 2009
  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

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Sindolor:
painless Injections
Subcutaneous Injections
Subcutaneous Injections to healthy volunteers

ClinicalTrials.gov processed this record on September 18, 2014