"Solana™ Trichomonas Assay Field Study"

Trichomonas Vaginalis Clinical Trial

Official title:

"Solana™ Trichomonas Assay Field Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566447
• Other study ID #: TV-01-2015
• Status: Completed
• First received: September 30, 2015
• Last updated: March 16, 2018
• Start date: October 15, 2015
• Est. completion date: August 15, 2016

Study information

• Verified date: August 2017
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginalis

Intervention

Device:
• Solana Trichomonas Assay Testing
Specimen collection of urine and/or vaginal swabs for testing

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina, Div. of Infectious Diseases	Chapel Hill	North Carolina
United States	University of Washington in Seattle	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trichomonas Test Result	Testing results will be received by testing site for current FDA cleared tests	2 days