HealthyNCT00684333
Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
A study testing painless subcutaneous injection by EZ-Ject Injector in people with Healthy, run by Sindolor at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- painless subcutaneous injection by EZ-Ject Injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- painless subcutaneous injection by EZ-Ject Injector
- Keywords
- painless Injections, Subcutaneous Injections, Subcutaneous Injections to healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painless subcutaneous injection by EZ-Ject InjectorDevice
EZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | volunteers Receives: Device: painless subcutaneous injection by EZ-Ject Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately
Secondary outcomes (1)
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).
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindolor
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacob Atsmon, M.D., Principal investigator, Ichilov Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684333
- Sponsor's protocol ID
- TRC 015/10062
- Status last verified
- Jan 2009
- First submitted
- 19 May 2008
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of EZ-Ject Injector a Novel Device for Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00684333
- Acronym / sponsor ID
- TRC 015/10062
- Conditions
- Healthy
- Keywords
- painless Injections, Subcutaneous Injections, Subcutaneous Injections to healthy volunteers
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- SindolorIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Device: painless subcutaneous injection by EZ-Ject Injectorvolunteers |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| painless subcutaneous injection by EZ-Ject InjectorEZ-Ject Injector device employee cutaneous local anesthesia on the injection site by an electronic anesthetic system | Device | group 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Atsmon, M.D. principal investigator
Ichilov Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painless subcutaneous injection by EZ-Ject Injector in people with Healthy, run by Sindolor at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.