Clinical trial: NCT03058705
Section: Confidentiality
Subsections: Privacy And Confidentiality:|Confidentiality Of Records

There is a minimal risk of invasion of privacy and loss of confidentiality since study personnel will have access to the data that we collect about you. However, we will protect the privacy and confidentiality of your information by assigning you a code number. The database generated in this study will be kept secured in a password protected computer program at the University of Rochester Medical Center.

The University of Rochester makes every effort to keep the information collected from you private. In order to do so, we will keep all collected data in a secured passwordprotected computer database program at the University of Rochester Medical Center.  
Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or study sponsors. If this does happen we will take precautions to protect the information you have provided. Results of the research may be presented at meetings or in publications, but your name will not be used. If you have never received a copy of the University of Rochester Medical Center (URMC) and Affiliates Notice of Privacy Practices, please ask the investigator for one. What information may be used and given to others? The study doctor will get your personal and medical information. For example:
- Research records
- Records about phone calls made as part of this research
- Past and present medical records related to the study
- Results of medical tests related to the study (imaging)
Who may use and give out information about you?  
- The study doctor and the study staff - URMC and Affiliates Your information may be given to:
- The Department of Health and Human Services
- The University of Rochester
- Imagin Medical
- The U.S. Food and Drug Administration (FDA) may also need to inspect study records at some point during the study or even after it has been completed. In the event that this should occur, every effort will be made to keep identifying information about you private.  
Why will this information be used and/or given to others?  
- To do the research
- To study the results
- To see if the research was done right If the results of this study are made public, information that identifies you will not be used. What if I decide not to give permission to use and give out my health information? Then you will not be able to be in this research study. May I review or copy my information? Yes, but only after the research is over. How long will this permission be valid? This permission will last indefinitely. May I cancel my permission to use and disclose information? Yes. You may cancel your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. Upon receiving the written notice, the study team will no longer use or disclose your health information and you will not be able to stay in this study. Information that has already been gathered may need to be used and given to others for the validity of the study.
Clinical trial: NCT03058705
Section: Participant's Rights
Subsections: Subject Consent

I have read (or have had read to me) the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I agree to participate in this study. I have received (or will receive) a signed copy of this form for my records and future reference. Subject Name (Printed by Subject)  Signature of Subject Date
Clinical trial: NCT03058705
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Participation

There are some risks to participating in this study. Known adverse effects of the Cysview include headache or procedural pain (1%-10%), bladder spasms (2%), bladder pain, painful urination, blood in your urine (<10%). Abnormal urine tests (urinalysis) and inflammation of the bladder (cystitis) have been reported (<1%). A generalized allergy (anaphylaxis) causing fainting, low blood pressure, difficulty breathing, shortness of breath, hives, rashes, nausea or vomiting has occurred (<1%). There are risks associated with foley catheter placement. The main risk of using a urinary catheter is that it can sometimes allow bacteria to enter the body. This risk is minimal because the catheter is only left for a short period of time, and placed in the sterile operating room. It is also possible to cause injury to the urethra (the tube that carries urine out of the body) when the catheter is inserted. This can cause future narrowing of the urethra because of scar tissue caused by catheter use. There is no increased risk from the use of the investigational light source. All medications and equipment components in contact with you are FDA-approved for use in this patient group. Clinical engineering electrical safety certification will be performed. Cystoscopic light sources approved for human use will be used, but at reduced near infrared intensity for imaging purposes; so less energy is introduced into your bladder than would normally occur.
Clinical trial: NCT03058705
Section: Procedures
Subsections: Description Of Study Procedures

While in the operating room when you are under general anesthesia, Cysview will be instilled into your bladder using a Foley catheter. The Cysview will sit in your bladder for up to 10 minutes. Then the Cysview will be drained out of your bladder via the Foley catheter which will then be removed. We will then insert the cystoscope into your bladder and use the investigational light source, which will be attached to the cystoscope, to view the interaction of Cysview and the bladder tumors. Use of the investigational light source might identify additional areas that the surgeon may want to biopsy. Once we have obtained images of your bladder and any tumors, you will undergo your routine transurethral resection of bladder tumor (TURBT) surgery. In addition, we will collect information about you from your medical record for the purposes of this research study.
Clinical trial: NCT03058705
Section: Purpose of Research
Subsections: Purpose And Background **Of Study**

The purpose of this study is to (1) determine if an investigational light source can aid in taking a biopsy and diagnosing bladder cancer and (2) whether using an investigational light source can potentially reduce the time Cysview has to sit in the bladder. Cysview is an FDA-approved drug that is instilled into the bladder to better identify bladder tumors while undergoing TURBT surgery. Currently, the Cysview is instilled into the bladder through a Foley catheter for approximately one hour before surgery. During your surgery, the investigational light source will be used with a cystoscope and Cysview. The cystoscope is an FDA-approved instrument that allows visualization of your bladder and bladder tumors.
Clinical trial: NCT03058705
Section: Voluntary Participation
Subsections: Voluntary Participation

Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you do withdraw from this study, the information you have already provided will be kept in a confidential manner. ************************************************************************
Clinical trial: NCT03058705
Section: Withdrawal from Study
Subsections: May I Withdraw From The Study?

Yes. If you withdraw your permission to be in the study, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. Is my health information protected after it has been given to others? No. There is a risk that your information will be given to others without your permission. 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 website at any time.