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Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

NCT01427023 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay. These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Conditions Studied

Interventions

  • DEVICE APTIMA Trichomonas vaginalis (ATV) Assay

Study Locations (7)

Alabama

  • University of Alabama, Birmingham — Birmingham

Indiana

  • Wishard Hospital - Indiana University School of Medicine — Indianapolis

Louisiana

  • Louisiana State University — New Orleans

Massachusetts

  • New England Center for Clinical Research — Fall River

North Carolina

  • University of North Carolina, Chapel Hill — Chapel Hill

Tennessee

  • Geneuity Clinical Research Services — Maryville

Texas

  • Planned Parenthood Gulf Coast — Houston

Trial Details

FieldValue
Enrollment Target 532 participants
Start Date 2012-08
Est. Completion 2013-12

Sponsor

Gen-Probe, Incorporated

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01427023

The ClinicalTrials.gov registry entry for NCT01427023 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gen-Probe, Incorporated, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Trichomonas Vaginalis appearing as the primary indexed condition, and to 1 intervention — of which APTIMA Trichomonas vaginalis (ATV) Assay is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01427023 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Alabama, Indiana, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01427023 about?

NCT01427023 is a clinical study titled "Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing". The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay. These specimens will be used to demonstrate assay perfo...

What is the current status of trial NCT01427023?

This trial is currently completed. The enrollment target is 532 participants. The study started on 2012-08. Estimated completion is 2013-12.

What conditions does trial NCT01427023 study?

This clinical trial studies the following conditions: Trichomonas Vaginalis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01427023?

The interventions under investigation include: APTIMA Trichomonas vaginalis (ATV) Assay (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01427023?

This trial is sponsored by Gen-Probe, Incorporated, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01427023 being conducted?

This trial has 7 study locations across Alabama, Indiana, Louisiana, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial