At a glance
ClinicalIndex Comparison RecordN/ACompleted· 132 enrolled
Drug / intervention
Test Device-Strip Format +2 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.
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
In Brief
An observational study evaluating Test Device-Strip Format, Test Device-Cassette Format, and 1 other intervention for Pregnancy. Completed, enrolled 132 participants across 6 sites.
Detailed Summary
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesUnited States
CollaboratorsNova Clinical Solutions, Inc.
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedDec 2019
Primary CompletionDec 2020
TodayJul 2026
First PostedDec 23, 2019
Enrollment StartDec 5, 2019
Primary CompletionDec 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.5 years ago
Interventions
Test Device-Strip Formatdevice
Sponsor's investigational device
Test Device-Cassette Formatdevice
Sponsor's investigational device
Predicate Devicedevice
Commercially available device