Clinical Performance of the Diassess Influenza A and B Test
1 other identifier
interventional
567
1 country
1
Brief Summary
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 6, 2018
February 1, 2018
4 months
January 20, 2017
February 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
One (1) patient visit which is a time frame of one (1) hour
Study Arms (1)
Diassess Influenza A and B Test
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diassess Inc.lead
Study Sites (1)
University Health Care Center
Syracuse, New York, 13202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol Chen, PhD
Diassess Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 30, 2017
Study Start
December 29, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
February 6, 2018
Record last verified: 2018-02