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NCT01427023 · ClinicalTrials.gov registry record
Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing
A clinical trial of Trichomonas Vaginalis, sponsored by Gen-Probe, Incorporated.
- Completed
- Registry status
- 532
- Enrollment target
- 7
- Study locations
NCT01427023: Completed study of Trichomonas Vaginalis, sponsored by Gen-Probe, Incorporated.
NCT01427023 is a study of Trichomonas Vaginalis that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 532 participants. The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427023, a study of Trichomonas Vaginalis, has completed, sponsored by Gen-Probe, Incorporated.
- COMPLETED
- Registry status
- 532 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
Positive Percent Agreement Using the TIGRIS Instrument as a Reference.
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
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2012-08 |
| Est. Completion | 2013-12 |
What the finished NCT01427023 record still lists
NCT01427023 is an observational study that tracks outcomes without assigning an intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT01427023 lists 7 locations in 7 states (Alabama, Indiana, Louisiana).
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.
What interventions are being tested in trial NCT01427023?
The interventions under investigation include: APTIMA Trichomonas vaginalis (ATV) Assay (DEVICE).
Who is sponsoring clinical trial NCT01427023?
This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
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