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CompletedNCT02886468DEEPUpdated Jun 24, 2026

DEpth of EPinephrine Delivery With Auto-injectors Devices

An interventional study of skin ultrasound in Anaphylactic Shock, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Although there are several causes of fatal anaphylaxis, food allergy is one of the most common. Epinephrine is recommended as the initial treatment of choice for anaphylaxis. A delay in epinephrine administration may contribute to an increased risk of death. Therefore, the World Allergy Organization recommends that, for the treatment of anaphylaxis, epinephrine solution be administered intramuscularly in the mid-anterolateral thigh.

In France 3 auto-injector pens are available: Anapen®, Epipen® and Jext®. For weight> 30 kg, the devices have a needle size respectively of 7.49 mm, 15.02 mm and 15.36 mm. For the weights between 15 and 30 kg needle size is 7.49 mm to 12.7 mm and Anapen® for Epipen® and Jext®.

Several studies suggest that the needle length needle is sometim

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Conditions studied

  • Anaphylactic Shock

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In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's enrollment of 107 is above the median of 40 across 50 interventional studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • a weight of over 30 kg at Baseline
  • with food or an Hymenoptera venom allergy (diagnosed by skin tests or serum-specific IgE testing, requiring prescription epinephrine auto-injector pen according to European recommendations,

Exclusion criteria

Exclusion Criteria:

  • having a skin lesion on the lateral aspect of the thigh,
  • with a known or suspected allergy to the contact gel
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    ultrasound images

    ultrasound images of the anterolateral aspect of the mid-right thigh

    Other: skin ultrasound

Interventions

  • Otherskin ultrasound
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What researchers measure

Primary outcomes

  1. Skin-to-muscle and muscle-to-bone distance assessment, with compression, for intramuscular injection depending on needle length of the auto-injector pen.

    Time frame: Day 1

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Study locations

1 site
  • Chr Metz Thionville
    Metz, 57085, France
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References and documents

Publications

  • Lefevre S, Goetz C, Hennequin L, Zevering Y, Dinot V. Frequencies and predictors of subcutaneous and intraosseous injection with 4 epinephrine autoinjector devices. Ann Allergy Asthma Immunol. 2024 Aug;133(2):194-202.e5. doi: 10.1016/j.anai.2024.05.002. Epub 2024 May 11. PubMed 38740133 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in May 2021, 56 months.

Of 13 interventional studies with no phase under Anaphylaxis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 56 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2016
First posted
Sep 1, 2016
StartActual
Aug 26, 2016
Primary completionActual
May 4, 2021
CompletionActual
Aug 16, 2021
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02886468
Responsible party
Sponsor
First posted
Sep 1, 2016
Start date
Aug 26, 2016
Primary completion
May 4, 2021
Completion
Aug 16, 2021
Last update
Jun 24, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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