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The purpose of this study is to evaluate a different type of medical equipment called "High-Resolution Microendoscope" for the diagnosis of cervical pre-cancerous lesions and cervical cancer. We want to compare the patients' clinical findings using the current equipment that we have in clinic with the clinical findings using the new equipment that we are testing on this research project. If the new equipment is proven to give comparable findings with the current equipment that we are using, doctors might be able to offer a diagnosis and treat cervical lesions in one visit. It might not be necessary to wait for cervical biopsies to come back before women would receive the indicated treatment. You are being asked to participate because you have been diagnosed with an abnormal PAP smear, and you need to have a colposcopic examination to determine the reason for your abnormal PAP smear and receive treatment.
You will start your examination with the colposcopic evaluation using the current equipment as determined by standard of care. But, if cervical biopsies are indicated, before performing your biopsies, for research purposes only- we will:
- Apply a substance called Proflavine 0.01% to your cervix
- We will re-evaluate your cervix with the new equipment we are testing- The High- Resolution Microendoscope
- After completing this re-evaluation, we will continue with the standard of care protocol and will perform your cervical biopsies if indicated.
The entire re-evaluation with the new equipment should add less than 10 minutes to the standard examination.
When a woman is found to have an abnormal PAP smear, depending on the findings and clinical history, most women will need to be further evaluated with a colposcope in order to understand the reason for the abnormal PAP and determine the best 2 of 7 treatment. This is called colposcopic examination and it is the standard of care. This procedure is performed in the clinic, patient is positioned on the examining table the same way she is positioned for a Pap smear, a speculum is placed inside the vaginal canal, and certain substances are applied to the cervix in order to identify cervical lesions. These substances might include acetic acid and/or lugol. The application of these substances helps to delineate the abnormal cervical areas that might need to be biopsied. For the purpose of this research study, before obtaining the biopsies, a second evaluation will be performed using the equipment that is being studied (High- Resolution Microendoscope) and using a different substance that will be applied to the cervix. This substance is called Proflavine 0.01%. Proflavine is a substance that has been used in fluorescent imaging around the world without any adverse effect reported.
This second evaluation should not take more than 10 minutes. After completing this second evaluation, your clinical examination and clinical visit should continue as routine.
There are no known risks associated with the equipment that will be used in this study.
The Food and Drug Administration (FDA) has also determined that the device that we will use during this research study meets the definition of non-significant risk device under the FDA regulations.
The anticipated total number of subjects involved in the study will be 250 women. All these anticipated participating women would be from The University of Texas Medical Branch. The length of time for your participation is 1 year. However, during your year of enrollment you might have only one examination, during one of your visits, using the research equipment.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Malignant Neoplasms of Female Genital Organs
Proflavine, High-Resolution Microendoscopy (HRME)
University of Texas Medical Branch Cancer Stop McAllen Clinic
Not yet recruiting
M.D. Anderson Cancer Center
Published on BioPortfolio: 2016-03-22T06:23:23-0400
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