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Clinical Evaluation of Polarized Light Assisted Colposcopy


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia

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Trial Information

Clinical Evaluation of Polarized Light Assisted 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

8-10 months

Safety Issue:

No

Principal Investigator

Daron Ferris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Geogia Health Sciences University

Authority:

United States: Institutional Review Board

Study ID:

CA156166

NCT ID:

NCT01349621

Start Date:

April 2011

Completion Date:

April 2013

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Abnormal Pap results
  • Colposcopy
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

Georgia Health Sciences UniversityAugusta, Georgia  30912