Assessment of the Clinical Performance of the ARROW-FLU System
NCT ID: NCT02996136
Last Updated: 2016-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
3000 participants
INTERVENTIONAL
2016-12-31
2017-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The ARROW-FLU Influenza A\&B Test system will be performed at CLIA-waived and non-CLIA waived clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g. nurses, physician assistants, medical assistants, etc).
A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. After standard of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject enrolled in the study. The swabs will be collected from the same nostril and alternated in their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and the other for reference testing. Any swab specimens required for standard of care testing will be collected prior to the specimens for this investigation. Investigational device operators will be blinded to standard of care testing results.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nasal Swab
Nasal Swab
Flu Symptoms
Flu Symptoms
Nasopharyngeal Swab
Nasopharyngeal Swab
Flu Symptoms
Flu Symptoms
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flu Symptoms
Flu Symptoms
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Preliminary assessment of the subject by the Investigator/Designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as both
* Presentation within that last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and
* At least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.
3. Written informed consent must be obtained prior to study enrollment:
1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
2. The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the clinical site's IRB).
Exclusion Criteria
2. The subject is undergoing treatment currently or within the past seven (7) days of the study visit with either
* A nasally-administered influenza vaccine (FluMist)
* Anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu), or Ribavirin.
3. The subject is currently receiving or has received within the past thirty (30) days of the study visit anu experimental biologic, drug, or device including either treatment or therapy.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beaufort CRO
INDUSTRY
Sekisui Diagnostics, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daiva Schmidt
Role: STUDY_DIRECTOR
Sekisui Diagnostics, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Avant Research Associates LLC
Crowley, Louisiana, United States
Tristan Medical Research Center / Regeneris Medical
North Attleboro, Massachusetts, United States
Children's Mercy
Kansas City, Missouri, United States
Accent Clinical Vegas
Las Vegas, Nevada, United States
Wake Research Associates
Raleigh, North Carolina, United States
Clinical Research Solutions LLC (Ohio)
Middleburg Heights, Ohio, United States
Clinical Research Solutions LLC (Tennessee)
Smyrna, Tennessee, United States
Marshfield Clinic
Eau Claire, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Steve Simpson, MD
Role: primary
Jeffrey Rosen, MD
Role: primary
Jason Haffizulla, MD
Role: primary
Donna Mayne, BS (MT) ASCP
Role: primary
Thomas Davis, MD, PhD
Role: primary
Dana King, MD
Role: primary
Satinder Saini, MD
Role: primary
Ryan Welter, MD
Role: primary
Rangaraj Selvarangan, PhD
Role: primary
Rogelio Machuca, MD
Role: primary
Wayne Harper, MD
Role: primary
John Panuto, MD
Role: primary
Sadia Dar, MD
Role: primary
Julia Kyle, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FLU-001-15
Identifier Type: -
Identifier Source: org_study_id