NCT02566447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
Last Updated

March 20, 2018

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

September 30, 2015

Last Update Submit

March 16, 2018

Conditions

Trichomonas Vaginalis

Outcome Measures

Primary Outcomes (1)

  • Trichomonas Test Result

    Testing results will be received by testing site for current FDA cleared tests

    2 days

Study Arms (1)

Symptomatic

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

Device: Solana Trichomonas Assay Testing

Interventions

Solana Trichomonas Assay TestingDEVICE

Specimen collection of urine and/or vaginal swabs for testing

Symptomatic

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female subjects symptomatic for Trichomonas vaginalis infection.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

University of North Carolina, Div. of Infectious Diseases

Chapel Hill, North Carolina, 27599-7030, United States

Location

University of Washington in Seattle

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Trichomonas vaginalis in vaginal swabs and urine samples

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

October 15, 2015

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

March 20, 2018

Record last verified: 2017-08

Locations

US(4)