Trichomonas VaginalisNCT02566447
"Solana™ Trichomonas Assay Field Study"
An observational study of Trichomonas Vaginalis, run by Quidel Corporation at 4 sites in United States.
Trial summary
The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Trichomonas Vaginalis
- What is being tested?
- Solana Trichomonas Assay Testing
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Oct 2015to 15 Aug 2016
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female subjects symptomatic for Trichomonas vaginalis infection.
Who may be able to join
- Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.
- Symptoms in women can include:
- Greenish-yellow, frothy vaginal discharge with a strong odor
- Painful urination
- Vaginal itching and irritation
- Discomfort during intercourse
- Lower abdominal pain (rare)
Who cannot join
- The study is limited to females. Male subjects are not accepted.
- At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of North Carolina, Div. of Infectious Diseases
Chapel Hill, North Carolina, 27599-7030
University of Washington in Seattle
Seattle, Washington, 98104
About this study
The Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.
Read the detailed description
This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.
- Conditions
- Trichomonas Vaginalis
- Being tested
- Solana Trichomonas Assay Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solana Trichomonas Assay TestingDevice
Specimen collection of urine and/or vaginal swabs for testing
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection. Receives: Device: Solana Trichomonas Assay Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trichomonas Test Result
Testing results will be received by testing site for current FDA cleared tests
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start15 Oct 2015
- Primary completion15 Aug 2016
- Study completion15 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonas VaginalisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566447
- Sponsor's protocol ID
- TV-01-2015
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Solana™ Trichomonas Assay Field Study"
- ClinicalTrials.gov ID
- NCT02566447
- Acronym / sponsor ID
- TV-01-2015
- Conditions
- Trichomonas Vaginalis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 2 Oct 2015 (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 Solana® Trichomonas Assay is an in vitro qualitative nucleic acid amplification test for the detection of Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Helicase-Dependent Amplification (HDA) technology and the Solana instrument.
Detailed description
This study is to establish the clinical performance of the Solana® Trichomonas Assay for the detection of Trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a FDA-cleared device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | Device: Solana Trichomonas Assay TestingSubjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female subjects symptomatic for Trichomonas vaginalis infection.
Key inclusion criteria (7 listed)
- Female subjects will be recruited from the general population as they present to the clinical facility. Subjects will be categorized by the clinician as either asymptomatic or symptomatic for Trichomonas vaginalis infection.
- Greenish-yellow, frothy vaginal discharge with a strong odor
- Painful urination
- Vaginal itching and irritation
- Discomfort during intercourse
Key exclusion criteria (2 listed)
- The study is limited to females. Male subjects are not accepted.
- At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
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 |
|---|---|---|
| Solana Trichomonas Assay TestingSpecimen collection of urine and/or vaginal swabs for testing | Device | Symptomatic |
Primary outcome
Trichomonas Test Result
Time frame: 2 days
Testing results will be received by testing site for current FDA cleared tests
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 20 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trichomonas Vaginalis, run by Quidel Corporation at 4 sites 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 7 inclusion and 2 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Trichomonas Test Result (time frame: 2 days). 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 20 Mar 2018.