Clinical Evaluation of Polarized Light Assisted Colposcopy
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2015 |
| Start Date: | April 2011 |
| End Date: | April 2013 |
| Contact: | Angela Goebel, BS, CCRC |
| Email: | agoebel@georgiahealth.edu |
| Phone: | 706-721-2535 |
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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