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COMPLETED NA

Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

NCT01944722 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 33,858 participants
Start Date 2013-08
Est. Completion 2016-03
Phase NA

Sponsor

Becton, Dickinson and Company

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01944722

The ClinicalTrials.gov registry entry for NCT01944722 describes a study currently listed as completed. It is categorized as NA, 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 33,858 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Becton, Dickinson and Company, which has 11 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 Uterine Cervical Neoplasms appearing as the primary indexed condition, and to 2 interventions — of which Colposcopy 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: NCT01944722 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Arizona, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01944722?

The interventions under investigation include: Colposcopy (PROCEDURE), BD Onclarity™ HPV assay on BD Viper™ LT (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01944722?

This trial is sponsored by Becton, Dickinson and Company, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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