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OpenTrials
Completed

NCT Number: NCT01359111

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.

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Key information

Conditions

Injections, Intradermal

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PATH ID Adapter

Device

Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of Participants With Safety Events

    Time frame: 2 days

    The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.

  2. Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

PATH

Other

Registry information

Official study title

Phase I Performance and Safety Evaluation of an Intradermal Delivery Device

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 24, 2011
Registry last updated
May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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