"Solana™ Trichomonas Assay Field Study"

NCT ID: NCT02566447

Last Updated: 2018-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-15

Study Completion Date

2016-08-15

Brief Summary

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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

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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

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Trichomonas Vaginalis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic

Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.

Solana Trichomonas Assay Testing

Intervention Type DEVICE

Specimen collection of urine and/or vaginal swabs for testing

Interventions

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Solana Trichomonas Assay Testing

Specimen collection of urine and/or vaginal swabs for testing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

1. The study is limited to females. Male subjects are not accepted.
2. At clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Quidel Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

University of North Carolina, Div. of Infectious Diseases

Chapel Hill, North Carolina, United States

Site Status

University of Washington in Seattle

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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TV-01-2015

Identifier Type: -

Identifier Source: org_study_id

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