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

Anaphylaxis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854969
• Other study ID #: AnapphylaxisQoL
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 25, 2017
• Start date: May 2016
• Est. completion date: July 18, 2017

Study information

• Verified date: August 2016
• Source: Adan Medical Innovation, SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 18, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaphylaxis

Intervention

Behavioral:
• Device: Anapphylaxis

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Adan Medical Innovation, SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction through a questionnaire in the use of the medical device		3 months
Secondary	Medical device safety	Adverse events related to the medical device	3 months
Secondary	Patient Adherence to the medical device through a questionnaire		3 months