Influenza, HumanNCT03035396
Clinical Performance of the Diassess Influenza A and B Test
A study testing Diassess Influenza A and B Test in people with Influenza, Human and Influenza, run by Diassess Inc. at 1 site in United States.
Trial summary
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza, Human, Influenza, Flu
- What is being tested?
- Diassess Influenza A and B Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Care Center
Syracuse, New York, 13202
About this study
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test
- Conditions
- Influenza, Human, Influenza, Flu
- Being tested
- Diassess Influenza A and B Test
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diassess Influenza A and B TestDevice
| Study group | Role | What they receive |
|---|---|---|
| Diassess Influenza A and B Test | Experimental | Not described Receives: Device: Diassess Influenza A and B Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Measured: One (1) patient visit which is a time frame of one (1) hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start29 Dec 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diassess Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Chen, PhD, Study director, Diassess Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035396
- Sponsor's protocol ID
- DIA 01A-CLI-002
- Status last verified
- Feb 2018
- First submitted
- 20 Jan 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Diassess Influenza A and B Test
- ClinicalTrials.gov ID
- NCT03035396
- Acronym / sponsor ID
- DIA 01A-CLI-002
- Conditions
- Influenza, Human, Influenza, Flu
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Diassess Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diassess Influenza A and B Test | Experimental | Device: Diassess Influenza A and B Test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diassess Influenza A and B Test | Device | Diassess Influenza A and B Test |
Primary outcome
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Time frame: One (1) patient visit which is a time frame of one (1) hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Chen, PhD study director
Diassess Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diassess Influenza A and B Test in people with Influenza, Human and Influenza, run by Diassess Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diassess test measurement agreement with Polymerase Chain Reaction (PCR) (time frame: One (1) patient visit which is a time frame of one (1) hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.