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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04098900
Other study ID # TP-000279
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2019
Est. completion date December 3, 2019

Study information

Verified date September 2019
Source Visby Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.


Recruitment information / eligibility

Status Completed
Enrollment 309
Est. completion date December 3, 2019
Est. primary completion date December 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 99 Years
Eligibility Inclusion Criteria:

1. Willing and able to give voluntary written informed consent and assent form (or the parental/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 greater than or equal to 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 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 judgement, could jeopardize the subjects's safety, or could interfere with study procedures.

2. Enrollment in the DMID 18-0024 and 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.

Study Design


Intervention

Diagnostic Test:
Click Sexual Health Test
The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.

Locations

Country Name City State
United States Therafirst Medical Center Fort Lauderdale Florida
United States Planned Parenthood Gulf Coast Houston Texas
United States Lawrence OB/GYN Clinical Research, LLC Lawrenceville New Jersey
United States Planned Parenthood of the St. Louis Region and Southwest Missouri Saint Louis Missouri
United States Planned Parenthood North Central States Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Visby Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percent sensitivity and specificity of the Click Device for detection of CT in self-collected vaginal specimens as compared to Patient Infected Status (PIS) using vaginal specimens collected by a qualified Health Care Provider (HCP) up to 6 months
Primary The percent sensitivity and specificity of the Click Device for detection of NG in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP up to 6 months
Primary The percent sensitivity and specificity of the Click Device for detection of TV in self-collected vaginal specimens as compared to PIS using vaginal specimens collected by a qualified HCP up to 6 months
Secondary Usability will be measured by 5-point Likert scale responses, yes/no questions, and open text questions from study operators. Questions are around three domains of interest: i) instructions, ii) operations, and iii) visual interpretation for the Click device for detection of CT, NG, and TV with patient self-collected specimens.
The 5-point Likert scale will measure responses to questions in the form of: (1) Strongly Disagree, (2) Disagree, (3) Neutral, (4) Agree, and (5) Strongly Agree
up to 6 months
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