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Clinical Study of a Diagnostic Device for NG, TV and CT in Women

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ClinicalTrials.gov Identifier: NCT03852316
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date November 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • The percent sensitivity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP). [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP. [ Time Frame: Up to 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03852316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • The percent sensitivity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device using self-collected vaginal swabs for detection of Chlamydia trachomatis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device using self-collected vaginal swabs for detection of Neisseria gonorrhoeae from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent sensitivity of Click device using self-collected vaginal swabs for detection of Trichomonas vaginalis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Chlamydia trachomatis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Neisseria gonorrhoeae in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device for detection of Trichomonas vaginalis in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among asymptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device using self-collected vaginal swabs for detection of Chlamydia trachomatis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device using self-collected vaginal swabs for detection of Neisseria gonorrhoeae from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
  • The percent specificity of Click device using self-collected vaginal swabs for detection of Trichomonas vaginalis from self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP among symptomatic subjects. [ Time Frame: Up to 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of a Diagnostic Device for NG, TV and CT in Women
Official Title  ICMJE Pivotal Study of a Single-Use, Point-of-Care Molecular Diagnostic Device for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
Brief Summary This is a multi-center study with a minimum of three sites in the United States. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit. The primary objective is to assess the performance of the Click device for detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens as compared to Patient Infected Status (PIS) determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance. and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
Detailed Description This is a multi-center study with a minimum of three clinical sites across diverse geographical areas in the United States. Approximately one-third of the total number of sites will have a patient population of low Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), or Trichomonas vaginalis (TV) prevalence. Low prevalence sites are defined as sites with a prevalence < / = 2 percent for any of the three targets. Sites with a prevalence higher than 2 percent for any of the three targets will be defined as high prevalence sites. The study will enroll approximately 1750 female subjects, 14 years of age and older, and will have a study duration of approximately 9 months after enrollment of the first subject. Female subjects seen at the participating sites for any reason will be evaluated for enrollment in this study. All subjects will be managed per standard of care as applicable. Subjects who are enrolled in the study will perform self-collection of a vaginal swab to be tested by Click device and allow the health care provider (HCP) to collect three additional vaginal swabs to be tested by recognized FDA-cleared comparator methods. Subjects will complete the study in a single visit, approximately 60 minutes in length. The hypothesis of this study is that Click Diagnostics Sexual Health Test performs substantially equivalent to the NAAT (Nucleic Acid Amplification Test) predicate system, and the identification of each organism (CT, NG, and TV) in self-collected vaginal swabs by women using the Click device will agree with the Patient Infected Status (PIS) with a high sensitivity and specificity. The primary objective is to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance and a Clinical Laboratory Improvement Amendments (CLIA) Waiver. The secondary objectives are: 1) to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens among symptomatic subjects as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP; 2) to assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens among asymptomatic subjects as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Chlamydial Infection
  • Gonococcal Infection
  • Trichomoniasis
Intervention  ICMJE Device: Click Device
A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.
Study Arms  ICMJE Experimental: Click Device
Each subject (females 14 years of age and older) will perform a self-collection vaginal swab for the Click device and be randomized to a particular order for three vaginal swab collections (performed by Health Care Providers (HCP) as defined by state/local regulatory authorities) for comparator methods. N=1750
Intervention: Device: Click Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2019)
1750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 24, 2019
Estimated Primary Completion Date November 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Willing and able to give voluntary written informed consent (or the parent/legal guardian will provide parental permission) before any study-related procedure is performed.
  2. Female at birth. (Pregnant and breastfeeding women are eligible.)
  3. Age > / = 14 years at the time of enrollment.
  4. Able to read and understand the procedural information provided for the study.
  5. Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a licensed HCP to collect three additional vaginal swabs.

Exclusion Criteria:

  1. Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures.
  2. Enrollment in this study previously.
  3. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sheldon Morris 16195434761 shmorris@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03852316
Other Study ID Numbers  ICMJE 18-0024
HHSN272201300014I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date February 20, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP