Injections, IntradermalPhase 1NCT01359111
Performance and Safety Evaluation of an Intradermal Delivery Device
A Phase 1 study testing PATH ID Adapter in people with Injections, Intradermal, run by PATH at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Injections, Intradermal
- What is being tested?
- PATH ID Adapter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male participants ages 18 to 55 years.
- Healthy enough to participate in the clinical trial per site investigator assessment.
- Healthy skin on the upper deltoid region of both arms.
- Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
- Literate in English.
- Available by telephone 48 hours after the study visit.
Who cannot join
- Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
- Unable to understand the study purpose or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: Phase I Performance and Safety Evaluation of an Intradermal Delivery Device
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
- Conditions
- Injections, Intradermal
- Being tested
- PATH ID Adapter
- Keywords
- Intradermal injections, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH ID AdapterDevice
Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Injections Delivered to the Intradermal Layer of the Skin
The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.
Measured: 1 day
Secondary outcomes (2)
Proportion of Participants With Safety Events
The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.
Measured: 2 days
Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.
The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injections, IntradermalStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Klaff, MD, PhD, Principal investigator, Rainier Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359111
- Sponsor's protocol ID
- HS 563
- Status last verified
- May 2012
- First submitted
- 2 May 2011
- Last updated
- 18 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Performance and Safety Evaluation of an Intradermal Delivery Device
- ClinicalTrials.gov ID
- NCT01359111
- Acronym / sponsor ID
- HS 563
- Conditions
- Injections, Intradermal
- Keywords
- Intradermal injections, Vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Posted 11 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male participants ages 18 to 55 years.
- Healthy enough to participate in the clinical trial per site investigator assessment.
- Healthy skin on the upper deltoid region of both arms.
- Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
- Literate in English.
Key exclusion criteria (2 listed)
- Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
- Unable to understand the study purpose or procedures.
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 |
|---|---|---|
| PATH ID AdapterIntradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. | Device | – |
Primary outcome
Proportion of Injections Delivered to the Intradermal Layer of the Skin
Time frame: 1 day
The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.
2 secondary outcomes
Proportion of Participants With Safety Events
Time frame: 2 days
Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leslie Klaff, MD, PhD principal investigator
Rainier Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PATH ID Adapter in people with Injections, Intradermal, run by PATH 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 6 inclusion and 2 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 18 May 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Injections Delivered to the Intradermal Layer of the Skin (time frame: 1 day). 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 18 May 2012.