Clinical Evaluation of Polarized Light Assisted Colposcopy
Completed
Conditions studied: Cervical Intraepithelial Neoplasia
In brief
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.
Key facts
- Study ID
- NCT01349621
- Run by
- Augusta University
- People needed
- 330
- Starts
- 2011-04-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2015-03-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Subject is female, 18 years or older
- Subject has previously detected abnormal cervical cytology or other indication for colposcopy
- Subject fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent
You may not qualify if…
- Subject is pregnant or may be pregnant
- Subject has known allergy to acetic acid
- Subject has thrombocytopenia or other coagulation disorder that would contraindicate obtaining multiple cervical biopsies
- Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
- Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
- Subject has clinical evidence of gross purulent cervicitis
- Subject has a recent history of acute cervicitis
- Subject does not have an intact cervix uteri or has more than one cervix uteri
Where it is running
- Georgia Health Sciences University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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