Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Public ClinicalTrials.gov record NCT01944722. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.
Study identification
- NCT ID
- NCT01944722
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 33,858 participants
Conditions and interventions
Conditions
Interventions
- BD Onclarity™ HPV assay on BD Viper™ LT Device
- Colposcopy Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2013
- Primary completion
- Feb 29, 2016
- Completion
- Feb 29, 2016
- Last update posted
- Jun 11, 2018
2013 – 2016
United States locations
- U.S. sites
- 41
- U.S. states
- 23
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| Mobile OB/GYN | Mobile | Alabama | 36608 | — |
| Women's Health Research of Arizona | Phoenix | Arizona | 85015 | — |
| Quality of Life Medical & Research Center | Tucson | Arizona | 85712 | — |
| Visions Clinical Research | Tucson | Arizona | 85712 | — |
| Women's Health Care Research Corp | San Diego | California | 92111 | — |
| West Coast Medical Research | San Diego | California | 92123 | — |
| Blueskies Center for Women | Colorado Springs | Colorado | 80910 | — |
| Health Awareness Inc | Jupiter | Florida | 33458 | — |
| Altus | Lake Worth | Florida | 33461 | — |
| Segal Institute for Clinical Research | North Miami | Florida | 33161 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| Medical Network for Education and Research | Decatur | Georgia | 30033 | — |
| Fellows Research Associates - Savannah | Savannah | Georgia | 31406 | — |
| Women's Health Practice | Champaign | Illinois | 61820 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Four Rivers Clinical Research | Paducah | Kentucky | 42003 | — |
| Louisiana State University | New Orleans | Louisiana | 70112 | — |
| Saginaw Valley Medical Research | Saginaw | Michigan | 48604 | — |
| Transgenomics | Omaha | Nebraska | 68164 | — |
| Vitura / Phoenix | Moorestown | New Jersey | 08057 | — |
| Meridian Health | Neptune City | New Jersey | 07753 | — |
| Q Squared Solutions | Teterboro | New Jersey | 07608 | — |
| TriCore Reference Laboratory | Albuquerque | New Mexico | 87102 | — |
| Research Pathology Associates, LLC | Irvington | New York | 10533 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| LabCorp | Burlington | North Carolina | 27215 | — |
| Eastern Carolina Women's Center | New Bern | North Carolina | 28562 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| HWC Women's Research Center | Englewood | Ohio | 45322 | — |
| Center for Women's Health of Lansdale | Lansdale | Pennsylvania | 19446 | — |
| Clinical Research of Philadelphia | Philadelphia | Pennsylvania | 19114 | — |
| Reading Health Physicians Network | West Reading | Pennsylvania | 19611 | — |
| Fellows Research Associates - Bluffton | Bluffton | South Carolina | 29910 | — |
| James T Martin Jr, MD | North Charleston | South Carolina | 29406 | — |
| Chattanooga Medical Research | Chattanooga | Tennessee | 37404 | — |
| Center for Disease Detection (CDD) | San Antonio | Texas | 78233 | — |
| Physicians Research Options | Draper | Utah | 84020 | — |
| Research Pathology Associates | Earlysville | Virginia | 22936 | — |
| Tidewater Clinical | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01944722, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01944722 live on ClinicalTrials.gov.