Clinical trial: NCT02477124
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?

If you agree to take part in this study, there is no direct medical benefit to you. We hope that in the future the information learned from this study will benefit other people with your condition.
Clinical trial: NCT02477124
Section: Confidentiality
Subsections: Will My Information Be Kept Confidential?

Participation in research involves some loss of privacy. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal information may be viewed by individuals involved in this research and may be seen by people including those collaborating, funding, and regulating the study. We will share only the minimum necessary information in order to conduct the research. Your personal information may also be given out if required by law. In addition, your records may be reviewed in order to meet federal or state regulations. Reviewers may include representatives from the Food and Drug Administration, Calla Health and representatives of the Duke University Health System Institutional Review Board. If your research record is reviewed by any of these groups, they may also need to review your entire medical record. The study results will be retained in your research record for at least six years after the study is completed. At that time either the research information not already in your medical record will be destroyed or information identifying you will be removed from such study results at DUHS. Any research information in your medical record will be kept indefinitely.
Clinical trial: NCT02477124
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In This Study?|How Long Will I Be In This Study?

Approximately 500 people will take part in this study at five different hospitals and medical facilities. Approximately 50 people will take part in this study at Duke.

You will be in the study for about 5 to 10 minutes while the research procedures are preformed. Imaging time will take about 1 minute. You can choose to stop participating at any time without penalty or loss of any benefits to which you are entitled. However, if you decide to stop participating in the study, we encourage you to talk to your doctor first.
Clinical trial: NCT02477124
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks Of The Study?|What About Research Related Injuries?

The risks of this study are no greater than those of colposcopy or LEEP procedures on their own. There is, however, the potential risk of loss of confidentiality. Every effort will be made to keep your information confidential, however, this cannot be guaranteed. You may experience mild discomfort during the use of the probe and there may be risks not known at this time.

Immediate necessary medical care is available at DUMC in the event that you are injured as a result of your participation in this research study. However, there is no commitment by DUMC or your physician to provide monetary compensation or free medical care to you in the event of a study-related injury. For questions about the study or research-related injury, contact Dr. Schmitt at (919) 684-1165 during regular business hours, after hours and on weekends and holidays.
Clinical trial: NCT02477124
Section: Procedures
Subsections: What Is Involved In The Study?

If you agree to be in this study, you will be asked to sign and date this consent form. Then you will undergo standard of care colposcopy or LEEP. After this is completed, the images will be collected with the transvaginal colposcope. Use of the transvaginal colposcope is a research procedure, and the images collected with the transvaginal colposcope will not be used to determine your care. Then biopsies, if necessary, will be taken as part of your standard of care. If you are undergoing LEEP, then your tissue will be removed after imaging. After your procedures, the images from the colposcope and transvaginal colposcope will be compared. Participation in this study is voluntary. If you do not sign this consent form, you will continue to receive care, but not as a part of this study.
Clinical trial: NCT02477124
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to see if the transvaginal colposcope we are testing produces similar results to colposcopy for the screening of cervical cancer. In this study we are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
Clinical trial: NCT02477124
Section: Withdrawal from Study
Subsections: What About My Rights To Decline Participation Or Withdraw From The Study?

You may choose not to be in the study, or, if you agree to be in the study, you may withdraw from the study at any time. If you withdraw from the study, no new data about you will be collected for study purposes unless the data concern an adverse event (a bad effect) related to the study. If such an adverse event occurs, we may need to review your entire medical record. If you agree to allow your [tissue/blood/cells] to be kept for future research with identifying information that could link your sample to you, you are free to change your mind at any time. Your decision not to participate or to withdraw from the study will not involve any penalty or loss of benefits to which you are entitled, and will not affect your access to health care at Duke. If you do decide to withdraw, we ask that you contact Dr. Schmitt in writing and let him know that you are withdrawing from the study. His mailing address is 329 Baker House, DUMC 3084, Durham, NC 27710. Your data may be stored and shared for future research without additional informed consent if identifiable private information, such as your name and medical record number, are removed. If your identifying information is removed from your samples or data, we will no longer be able to identify and destroy them. The use of your data may result in commercial profit. You will not be compensated for the use of your data and samples other than what is described in this consent form. We will tell you about new information that may affect your health, welfare, or willingness to stay in this study. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.