Injections, IntradermalNCT01943110
Evaluation of the Performance and Safety of Two Intradermal Delivery Devices.
A study testing ID adapter (autodisable) and ID adapter (side load) 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 two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations 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?
- ID adapter (autodisable) and ID adapter (side load)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jul 2013
- Phase
- Interventional
- 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, suprascapular, and forearm regions (both sides of the body).
- 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, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.
The purpose of this study is to evaluate whether two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
Read the detailed description
This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).
Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
- Upper deltoid with the side-load ID adapter
- Upper deltoid with the autodisable (AD) ID adapter
- Suprascapular (behind the shoulder) with the side-load ID adapter
- Suprascapular with the AD ID adapter
- Forearm with the side-load ID adapter
- Forearm with the AD ID adapter
Intradermal administration of each injection will be assessed:
- The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
- The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
- A photo of the injection site will be taken.
Injections will be assessed for safety by observation of injection sites for any local adverse events.
- Conditions
- Injections, Intradermal
- Being tested
- ID adapter (autodisable), ID adapter (side load)
- Keywords
- Intradermal injections, Vaccine delivery devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID adapter (autodisable)Device
Also called Autodisable intradermal adapter, AD ID adapter
Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
ID adapter (side load)Device
Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
| Study group | Role | What they receive |
|---|---|---|
| Saline injection with ID adapters | Experimental | Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
* Upper deltoid with the side-load ID adapter
* Upper deltoid with the AD ID adapter
* Suprascapular (behind the shoulder) with the side-load ID adapter
* Suprascapular with the AD ID adapter
* Forearm with the side-load ID adapter
* Forearm with the AD ID adapter Receives: Device: ID adapter (autodisable); Device: ID adapter (side load) |
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 resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.
Measured: 1 day
Secondary outcomes (1)
Proportion of Injections With Safety Events
The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.
Measured: Within 30 minutes and within 48 hours of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2013
- Study completionJul 2013
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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- SID Technologies
- Responsible party
- Sponsor
- Investigators
- Leslie Klaff, MD, PhD, Principal investigator, Rainier Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943110
- Sponsor's protocol ID
- HS 720
- Status last verified
- Apr 2015
- First submitted
- 11 Sep 2013
- Last updated
- 2 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Performance and Safety of Two Intradermal Delivery Devices.
- ClinicalTrials.gov ID
- NCT01943110
- Acronym / sponsor ID
- HS 720
- Conditions
- Injections, Intradermal
- Keywords
- Intradermal injections, Vaccine delivery devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- SID Technologies
- Study start
- Jul 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Posted 19 Jun 2015
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 two intradermal (ID) vaccine delivery devices can safely and precisely inject liquid into the intradermal layer of the skin in three different injection locations
Detailed description
This study is a preliminary device safety and performance evaluation in healthy adult volunteers (ages 18-55 years).
Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:
- Upper deltoid with the side-load ID adapter
- Upper deltoid with the autodisable (AD) ID adapter
- Suprascapular (behind the shoulder) with the side-load ID adapter
- Suprascapular with the AD ID adapter
- Forearm with the side-load ID adapter
- Forearm with the AD ID adapter
Intradermal administration of each injection will be assessed:
- The liquid remaining on the surface of the skin will be blotted with absorbent paper and the amount of liquid present will be recorded.
- The formation of an intradermal wheal will be observed, and the diameter of the wheal measured using a ruler or similar measurement tool.
- A photo of the injection site will be taken.
Injections will be assessed for safety by observation of injection sites for any local adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saline injection with ID adapters | Experimental | Device: ID adapter (autodisable), Device: ID adapter (side load)Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin: * Upper deltoid with the side-load ID adapter * Upper deltoid with the AD ID adapter * Suprascapular (behind the shoulder) with the side-load ID adapter * Suprascapular with the AD ID adapter * Forearm with the side-load ID adapter * Forearm with the AD ID adapter |
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, suprascapular, and forearm regions (both sides of the body).
- Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
- Literate in English.
Key exclusion criteria (1 listed)
- Skin abnormalities on upper deltoid, suprascapular, and forearm regions of either side of the body (scars, rash, infection), tattoo at the injection site, or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
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 |
|---|---|---|
| ID adapter (autodisable)Also: Autodisable intradermal adapter, AD ID adapterIntradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse. | Device | Saline injection with ID adapters |
| ID adapter (side load)Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. | Device | Saline injection with ID adapters |
Primary outcome
Proportion of Injections Delivered to the Intradermal Layer of the Skin
Time frame: 1 day
The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.
1 secondary outcome
Proportion of Injections With Safety Events
Time frame: Within 30 minutes and within 48 hours of injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- 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 study testing ID adapter (autodisable) and ID adapter (side load) 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 1 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 2 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2015). 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 2 Mar 2016.