Status:

COMPLETED

A Healthcare Economic Study of the Click Sexual Health Test

Lead Sponsor:

Visby Medical

Conditions:

Sexually Transmitted Diseases

Eligibility:

FEMALE

14+ years

Brief Summary

This is a multicenter study with a minimum of three CLIA-Waived intended operator sites in which prospectively collected vaginal swab specimens will be evaluated with the Click Sexual Health Test as c...

Eligibility Criteria

Inclusion

  • Documentation that the subject has provided informed consent prior to conducting study procedures
  • Subject is symptomatic or asymptomatic for sexually transmitted infections
  • Subject is female and 14 years of age or older at the time of enrollment
  • Able and willing to follow study procedures

Exclusion

  • Subject has been previously enrolled in the study
  • Subject has a contraindication, medical condition, serious intercurrent illness or other circumstance that in the investigator's judgement, could jeopordize the subject's safety or could interfere with the study procedures
  • Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.

Key Trial Info

Start Date :

December 3 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 29 2021

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT04099199

Start Date

December 3 2019

End Date

March 29 2021

Last Update

December 1 2021

Active Locations (1)

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Premier Health

Baton Rouge, Louisiana, United States, 70809