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NCT01803113 · ClinicalTrials.gov registry record
Sofia hCG FIA Field Study
A clinical trial of Pregnancy, Early Detection, sponsored by Quidel Corporation.
- Completed
- Registry status
- 975
- Enrollment target
- 5
- Study locations
NCT01803113: Completed study of Pregnancy, Early Detection, sponsored by Quidel Corporation.
NCT01803113 is a study of Pregnancy, Early Detection that has completed, run by Quidel Corporation. The registered enrollment target is 975 participants. The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01803113, a study of Pregnancy, Early Detection, has completed, sponsored by Quidel Corporation.
- COMPLETED
- Registry status
- 975 participants
- Enrollment target
- 5
- Study locations
Study Summary
The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
Primary Outcome
Clinical performance will be based on comparison of Sofia hCG FIA test results to those obtained from an FDA-cleared hCG test.
Conditions Studied
Interventions
- DEVICE Sofia hCG FIA
Study Locations (5)
Massachusetts
- NECCR of Massachusetts, LLC - Fall River
- New England Center for Clinical Research Fall River,LLC (NECCR) - Fall River
Florida
- Jose Castaneda, MD - Boynton Beach
Rhode Island
- Partners In Obstetrics and Gynecology, Inc. - Pawtucket
Texas
- Planned Parenthood Gulf Coast - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 975 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-03 |
What the finished NCT01803113 record still lists
NCT01803113 is an observational study that tracks outcomes without assigning an intervention. The registered 975 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Pregnancy, Early Detection appearing as the primary indexed condition, and to 1 intervention - of which Sofia hCG FIA is the first listed.
NCT01803113 lists 5 locations in 4 states (Massachusetts, Florida, Rhode Island).
Frequently Asked Questions
What is clinical trial NCT01803113 about?
NCT01803113 is a clinical study titled "Sofia hCG FIA Field Study". The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.
What is the current status of trial NCT01803113?
This trial is currently completed. The enrollment target is 975 participants. The study started on 2013-01. Estimated completion is 2013-03.
What conditions does trial NCT01803113 study?
This clinical trial studies the following conditions: Pregnancy, Early Detection.
What interventions are being tested in trial NCT01803113?
The interventions under investigation include: Sofia hCG FIA (DEVICE).
Who is sponsoring clinical trial NCT01803113?
This trial is sponsored by Quidel Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01803113 being conducted?
This trial has 5 study locations across Florida, Massachusetts, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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