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Clinical Trials/NCT02854969
NCT02854969
Completed
Not Applicable

Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis

Adan Medical Innovation, SL1 site in 1 country100 target enrollmentMay 2016
ConditionsAnaphylaxis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anaphylaxis
Sponsor
Adan Medical Innovation, SL
Enrollment
100
Locations
1
Primary Endpoint
Patient satisfaction through a questionnaire in the use of the medical device
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
July 18, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years old or above
  • Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed
  • Patients with a smartphone
  • Patients who signed the informed consent

Exclusion Criteria

  • Patients who have not signed the informed consent
  • Patients with some limitations for understanding or following correctly the trial procedures
  • Pregnant or nursing women

Outcomes

Primary Outcomes

Patient satisfaction through a questionnaire in the use of the medical device

Time Frame: 3 months

Secondary Outcomes

  • Medical device safety(3 months)
  • Patient Adherence to the medical device through a questionnaire(3 months)

Study Sites (1)

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