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NCT01349621 · ClinicalTrials.gov registry record
Clinical Evaluation of Polarized Light Assisted Colposcopy
A clinical trial, sponsored by Augusta University.
- Completed
- Registry status
- 330
- Enrollment target
NCT01349621: Completed study, sponsored by Augusta University.
NCT01349621 is a clinical trial that has completed, run by Augusta University. The registered enrollment target is 330 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349621 has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- 330 participants
- Enrollment target
Study Summary
This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. His/her impression of the exam will be noted and if necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy using a polarized light. His/her impression of the exam will be noted and a biopsy specimen will be obtained if necessary. This study is designed to test the hypothesis that polarized light colposcopy is more sensitive and more specific than standard, un-polarized light colposcopy.
Primary Outcome
We will examine 300 women scheduled for colposcopy using unpolarized and polarized light. To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. We anticipate that it will take approximately 8-10 months to enroll 300 subjects.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-02 |
What the finished NCT01349621 record still lists
NCT01349621 is an observational study that tracks outcomes without assigning an intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01349621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349621 about?
NCT01349621 is a clinical study titled "Clinical Evaluation of Polarized Light Assisted Colposcopy". This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examinat...
What is the current status of trial NCT01349621?
This trial is currently completed. The enrollment target is 330 participants. The study started on 2011-04. Estimated completion is 2014-02.
Who is sponsoring clinical trial NCT01349621?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
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