"Solana™ Trichomonas Assay Field Study" | NCT02566447

Studies
"Solana™ Trichomonas Assay Field Study"

NCT02566447

Sponsor

Quidel Corporation

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

750Actual

Phase

Not provided

Conditions

Trichomonas Vaginalis

Interventions

Solana Trichomonas Assay Testing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2015Actual

Primary Completion Date

Aug 15, 2016Actual

Completion Date

Aug 15, 2016Actual

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Sep 30, 2015

First Posted Date

Oct 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2018

Last Update Posted Date

Mar 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

750Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Symptomatic		Subjects will be categorized by the clinician as symptomatic for Trichomonas vaginalis infection.	Device: Solana Trichomonas Assay Testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Solana Trichomonas Assay Testing	Device	Specimen collection of urine and/or vaginal swabs for testing	Symptomatic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trichomonas Test Result	Testing results will be received by testing site for current FDA cleared tests	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Female subjects symptomatic for Trichomonas vaginalis infection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Johns Hopkins University School of Medicine