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Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens

NCT02267876 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from the BDS-USHPV baseline results

Interventions

  • PROCEDURE Colposcopy
  • DEVICE BD HPV Assay on Viper LT

Study Locations (20)

Florida

  • Health Awareness Inc. — Jupiter
  • Altus Research — Lake Worth
  • Segal Institute for Clinical Research — North Miami
  • Miami Research Associates — South Miami
  • Comprehensive Clinical Trails, 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
  • Mobile OB/GYN — Mobile

Georgia

  • Medical Network for Education & Research — Decatur
  • Fellows Research Alliance - Savannah — Savannah

California

  • Women's Health Care Research Corp. — San Diego

Colorado

  • Blueskies Center for Women — Colorado Springs

Illinois

  • Women's Health Practice — Champaign

Indiana

  • Indiana University — Indianapolis

Trial Details

FieldValue
Enrollment Target 6,730 participants
Start Date 2014-10
Est. Completion 2019-05

Sponsor

Becton, Dickinson and Company

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02267876

The ClinicalTrials.gov registry entry for NCT02267876 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 6,730 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 2 conditions, with Human Papillomavirus 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: NCT02267876 reports 20 study locations spanning 12 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 NCT02267876 about?

NCT02267876 is a clinical study titled "Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens". The purpose of the study is to assess the cumulative disease detection of greater than or equal to Cervical intraepithelial neoplasia 2 (CIN2) and greater than or equal to Cervical intraepithelial neoplasia 3 (CIN3) in the subjects over 3 years using the subject's HPV status and cytology status from...

What is the current status of trial NCT02267876?

This trial is currently completed. The enrollment target is 6,730 participants. The study started on 2014-10. Estimated completion is 2019-05.

What conditions does trial NCT02267876 study?

This clinical trial studies the following conditions: Human Papillomavirus, 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 NCT02267876?

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

Who is sponsoring clinical trial NCT02267876?

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 NCT02267876 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