Trial Information

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of the Normal Cervix for Screening, Using a Second Generation Device

A colposcopy is an exam of the vagina and cervix using a magnifying lens. A multi-spectral
digital colposcopy uses a digital camera and a special light to take pictures of the cervix
and vagina.

Before taking part in this study, you will have a complete medical history recorded. You
will have a physical exam and a pap smear. Women who are able to have children must have a
negative urine pregnancy test.

You will then have a multi-spectral digital colposcopy performed during the routine
colposcopy in the outpatient clinic. A multi-spectral digital colposcopy device will shine
light on the cervix and vagina and take several pictures. The pictures will be used by the
doctors to check the cells and structure of the tissue. After the first set of pictures,
acetic acid (vinegar) will be applied to the cervix so any lesions would show up better.
Application of acetic acid is a normal part of the colposcopy and not part of the research.
About 1-2 minutes later, more pictures will be taken.

If the acetic acid/colposcopy show abnormal cells, you will have a biopsy of the cervical
canal.

If the acetic acid /colposcopy show normal cells, no biopsy will be taken.

Once you have completed the colposcopy with or without the biopsy of the cervical canal,
your participation on this study is complete.

If either your Pap smear or biopsy of the cervical canal is abnormal, the study doctor/staff
will recommend further care or treatment.