Clinical Performance of the Diassess Influenza A and B Test

NCT ID: NCT03035396

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

567 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-29

Study Completion Date

2017-05-31

Brief Summary

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The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Detailed Description

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Conditions

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Influenza, Human Influenza Flu

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Diassess Influenza A and B Test

Group Type EXPERIMENTAL

Diassess Influenza A and B Test

Intervention Type DEVICE

Interventions

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Diassess Influenza A and B Test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
* Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough

Exclusion Criteria

* Subject received nasal vaccine (e.g. FluMist) within the past 10 days
* Subject has been taking or took any antivirals for influenza in the past 30 days
* Subject enrolled in any drug trials
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diassess Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Chen, PhD

Role: STUDY_DIRECTOR

Diassess Inc.

Locations

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University Health Care Center

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DIA 01A-CLI-002

Identifier Type: -

Identifier Source: org_study_id

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