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NCT01359111 · ClinicalTrials.gov registry record · Phase 1

Performance and Safety Evaluation of an Intradermal Delivery Device

A Phase 1 study, sponsored by PATH.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01359111: Completed Phase 1 study, sponsored by PATH.

NCT01359111 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01359111, a Phase 1 study, has completed, sponsored by PATH.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE PATH ID Adapter

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-05
Est. Completion 2011-05
Phase Phase 1
PATH

18 total trials

What the finished NCT01359111 record still lists

NCT01359111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which PATH ID Adapter is the first listed.

NCT01359111 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01359111 about?

NCT01359111 is a clinical study titled "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.

What is the current status of trial NCT01359111?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-05. Estimated completion is 2011-05.

What interventions are being tested in trial NCT01359111?

The interventions under investigation include: PATH ID Adapter (DEVICE).

Who is sponsoring clinical trial NCT01359111?

This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01359111's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01359111, the US trial registry maintained by the National Library of Medicine. NCT01359111 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.