Clinical Performance of the Diassess Influenza A and B Test | NCT03035396

Studies
Clinical Performance of the Diassess Influenza A and B Test

NCT03035396

Sponsor

Diassess Inc.

Status

Completed

Last Update Posted

Feb 6, 2018Actual

Enrollment

567Actual

Phase

Not Applicable

Conditions

Influenza, Human
Influenza
Flu

Interventions

Diassess Influenza A and B Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 20, 2017

First Submission Date that Met QC Criteria

Jan 25, 2017

First Posted Date

Jan 30, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2018

Last Update Posted Date

Feb 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

567Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diassess Influenza A and B Test	Experimental		Device: Diassess Influenza A and B Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diassess Influenza A and B Test	Device		Diassess Influenza A and B Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)		One (1) patient visit which is a time frame of one (1) hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol Chen, PhD	Diassess Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Care Center		Syracuse	New York	13202	United States

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided