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NCT01944722 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
A NA study of Uterine Cervical Neoplasms, sponsored by Becton, Dickinson and Company.
- Completed
- Registry status
- NA
- Development phase
- 33,858
- Enrollment target
- 20
- Study locations
NCT01944722: Completed NA study of Uterine Cervical Neoplasms, sponsored by Becton, Dickinson and Company.
NCT01944722 is a NA study of Uterine Cervical Neoplasms that has completed, run by Becton, Dickinson and Company. The registered enrollment target is 33,858 participants, above the 1,321-participant average among 8 other Uterine Cervical Neoplasms trials with a reported enrollment target (2463% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01944722, a NA study of Uterine Cervical Neoplasms, has completed, sponsored by Becton, Dickinson and Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 33,858 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
Conditions Studied
Interventions
- PROCEDURE Colposcopy
- DEVICE BD Onclarity™ HPV assay on BD Viper™ LT
Study Locations (20)
Florida
- Health Awareness Inc - Jupiter
- Altus - Lake Worth
- Segal Institute for Clinical Research - North Miami
- Miami Research Associates - South Miami
- Comprehensive Clinical Trials, LLC - West Palm Beach
Arizona
- Women's Health Research of Arizona - Phoenix
- Quality of Life Medical & Research Center - Tucson
- Visions Clinical Research - Tucson
Alabama
- University of Alabama Birmingham - Birmingham
- Mobile OB/GYN - Mobile
California
- Women's Health Care Research Corp - San Diego
- West Coast Medical Research - San Diego
Georgia
- Medical Network for Education and Research - Decatur
- Fellows Research Associates - Savannah - Savannah
Colorado
- Blueskies Center for Women - Colorado Springs
Illinois
- Women's Health Practice - Champaign
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33,858 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT01944722 record still lists
NCT01944722 is an interventional study that assigns participants to a tested intervention. Its 33,858 participants enrollment target places it among the larger protocols in the corpus, above the 1,321-participant average among 8 other Uterine Cervical Neoplasms trials with a reported enrollment target (2463% higher).
The record links to 1 condition, with Uterine Cervical Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Colposcopy is the first listed.
NCT01944722 names 20 study sites across 11 states, led by Florida, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01944722 about?
NCT01944722 is a clinical study titled "Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens". 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 comp...
What is the current status of trial NCT01944722?
This trial is currently completed. It is a NA study. The enrollment target is 33,858 participants. The study started on 2013-08. Estimated completion is 2016-03.
What conditions does trial NCT01944722 study?
This clinical trial studies the following conditions: Uterine Cervical Neoplasms.
What interventions are being tested in trial NCT01944722?
The interventions under investigation include: Colposcopy (PROCEDURE), BD Onclarity™ HPV assay on BD Viper™ LT (DEVICE).
Who is sponsoring clinical trial NCT01944722?
This trial is sponsored by Becton, Dickinson and Company, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01944722 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01944722's enrollment target sits among peer trials
33,858 1st of 8 higher than 8 of 8 other Uterine Cervical Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uterine Cervical Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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