Expired Study
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Renton, Washington 98057


Purpose:

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.


Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.


Study is Available At:


Original ID:

HS 563


NCT ID:

NCT01359111


Secondary ID:


Study Acronym:


Brief Title:

Performance and Safety Evaluation of an Intradermal Delivery Device


Official Title:

Phase I Performance and Safety Evaluation of an Intradermal Delivery Device


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Program for Appropriate Technology in Health


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Leslie Klaff, MD, PhD
Principal Investigator
Rainier Clinical Research Center

Study Dates

Start Date:May 2011
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:July 18, 2011
First Received Date:May 2, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Proportion of injections administered with needle bevel up and needle bevel down delivered to the intradermal layer of the skin.
Time Frame:1 day
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Proportion of participants with safety events
Time Frame:2 days
Safety Issues:True
Description:The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.
Outcome Type:Primary Outcome
Measure:Proportion of injections delivered to the intradermal layer of the skin
Time Frame:1 day
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:PATH ID Adapter
Description:Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Program for Appropriate Technology in Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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