Functionality and Performance of DevicePharmaJetNCT01494571
Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
An observational study of Functionality and Performance of Device, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery. Read more about this study
- Who is it for?
- Ages 2 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Functionality and Performance of Device
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Sep 2012
- Phase
- Observational
- 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 2 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Up to 400 children, aged 2 months to 14 years
Who may be able to join
- Infants and children between ages 2 months and 14 years
- Outpatient, expected to go home day of surgery
- Written consent and assent when appropriate
- Willing to complete and return pain diary (postcard) after 48 hours
Who cannot join
- Presently have skin rash at the intended injection site
- Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
- Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
- Skin disorders that may predispose them to develop skin lesions at sites of trauma.
- Present use of any blood thinning medications.
- In the 10-11 year old cohort, none of the participants can have started puberty.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
Read the detailed description
Up to 400 children, ages 2 months through 14 years
- To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
- To document completeness of injections; completeness is defined as <10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
- To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.
- Conditions
- Functionality and Performance of Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 90 pediatric, 7 to 14 year old subjects | Not described | |
| 30 pediatric, 5 to 6 year old subjects | Not described | |
| 30 pediatric, 3 to 4 year old subjects | Not described | |
| 30 pediatric, 1 to 2 year old subjects | Not described | |
| 30 pediatric, 6 to 12 month old subjects | Not described | |
| 30 pediatric, 4 to 6 month old subjects | Not described | |
| 30 pediatric, 2 to 4 month old subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of injection
To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. Measurement of the bleb size following injection will recorded in millimeters.
Measured: within one minute after injection
Size of bleb on skin after injection
Measurement of the bleb size immediately following injection will be determined using a millimeter ruler
Measured: within 2 minutes after injection
Acceptability by subject
subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia.
Measured: up to 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functionality and Performance of DeviceStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Galinkin, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494571
- Sponsor's protocol ID
- 11-1362
- Acronym
- PharmaJet
- Status last verified
- Dec 2012
- First submitted
- 12 Dec 2011
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
- ClinicalTrials.gov ID
- NCT01494571
- Acronym / sponsor ID
- PharmaJet / 11-1362
- Conditions
- Functionality and Performance of Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Dec 2011 (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.
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
Detailed description
Up to 400 children, ages 2 months through 14 years
- To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
- To document completeness of injections; completeness is defined as <10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
- To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 90 pediatric, 7 to 14 year old subjects | – | – |
| 30 pediatric, 5 to 6 year old subjects | – | – |
| 30 pediatric, 3 to 4 year old subjects | – | – |
| 30 pediatric, 1 to 2 year old subjects | – | – |
| 30 pediatric, 6 to 12 month old subjects | – | – |
| 30 pediatric, 4 to 6 month old subjects | – | – |
| 30 pediatric, 2 to 4 month old subjects | – | – |
Who may qualify
- Ages
- 2 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Up to 400 children, aged 2 months to 14 years
Key inclusion criteria (4 listed)
- Infants and children between ages 2 months and 14 years
- Outpatient, expected to go home day of surgery
- Written consent and assent when appropriate
- Willing to complete and return pain diary (postcard) after 48 hours
Key exclusion criteria (6 listed)
- Presently have skin rash at the intended injection site
- Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
- Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
- Skin disorders that may predispose them to develop skin lesions at sites of trauma.
- Present use of any blood thinning medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completeness of injection
Time frame: within one minute after injection
To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings. Measurement of the bleb size following injection will recorded in millimeters.
Size of bleb on skin after injection
Time frame: within 2 minutes after injection
Measurement of the bleb size immediately following injection will be determined using a millimeter ruler
Acceptability by subject
Time frame: up to 48 hrs
subjects response to the injection-level of pain or discomfort. Subjects response will not be collected for those who opt to receive the injections while under anesthesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
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.
Jeffrey Galinkin, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functionality and Performance of Device, run by University of Colorado, Denver at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 7 Mar 2013. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Completeness of injection (time frame: within one minute after injection). The study lists 3 primary outcomes in all. 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 7 Mar 2013.