Skip to main content
OpenTrials
Completed

NCT Number: NCT02854969

Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Device: Anapphylaxis

Behavioral

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Medical device safety

    Time frame: 3 months

    Adverse events related to the medical device

  2. Patient Adherence to the medical device through a questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Adan Medical Innovation, SL

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
Jul 26, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.