CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33,858 enrolled
Drug / intervention
BD Onclarity™ HPV assay on BD Viper™ LT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01944722
NCT01944722N/ACompleted
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Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

Becton, Dickinson and Company·interventional·Posted Sep 18, 2013·Updated Jun 12, 2018

In Brief

A clinical study evaluating BD Onclarity™ HPV assay on BD Viper™ LT and Colposcopy for Uterine Cervical Neoplasms. Completed, enrolled 33,858 participants across 41 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cervical Neoplasms
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartAug 1, 2013
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.8 years ago

Interventions

BD Onclarity™ HPV assay on BD Viper™ LTdevice

The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.

Colposcopyprocedure

Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.