Thank you for participating in this critically important clinical research. Our study will help us develop better treatment protocols that will directly benefit you and men like you around the world. This survey should take no more than 3 minutes to complete. Responses to questions will remain completely anonymous. Your participation is greatly appreciated.
INFORMED CONSENT DOCUMENT
AGREEMENT TO BE IN A RESEARCH STUDY
 

NAME OF SPONSOR COMPANY:   AFFIRM Science Inc

PROTOCOL NUMBER AND TITLE OF STUDY: BRAND-001 “A Proof of Concept Study to evaluate safety, tolerability and preliminary efficacy of “Shockwave Therapy” for erectile function”

NAME OF PERSON IN CHARGE OF THE RESEARCH STUDY: Judson M. Brandeis, M.D.                      

TELEPHONE NUMBER(S), DAYTIME & AFTER HOURS: (925) 255-7867 and research@brandeismd.com

KEY INFORMATION
 

1. This is a research study and your participation is voluntary. 

2. The objective of this study is to examine and quantify the efficacy of Shockwave Therapy for the treatment of erectile dysfunction.

3. Shockwave Therapy is not currently indicated for use in treating erectile dysfunction.

4. Shockwave Therapy is a potentially long-lasting treatment option for erectile dysfunction.

5. You will be asked to complete a short, confidential questionnaire before and after treatment, and again at the 3rd, 6th, 9th and 12th month.

6. The benefit of participating in this study is to advance the understanding of Shockwave Therapy for erectile dysfunction in order to improve treatment protocols and better plan for long-term maintenance therapy. 

7. The downside of participating in this study is an initial time investment of 15 minutes and a future time investment of 3 minutes at 5 separate intervals.

8. The main benefit to you (or others) for taking part in this study is: to help other men that are also suffering with erectile dysfunction.

9. There are no risks of participating in the study; main risks of Shockwave Therapy include swelling and redness at the site of therapy during treatment. The complete list of risks/discomforts is listed later in this informed consent. 

10. The information collected in this study relates to medical conditions that affect the ability of blood to flow into the genitalia.

11. In consultation with your healthcare provider you have chosen to undergo Shockwave Therapy for the treatment of your vasculogenic erectile dysfunction.  It is important to understand that there are alternative treatments for vasculogenic erectile dysfunction; it is beyond the scope of this consent to list the pros and cons of the different treatment options, but the study doctor can discuss these options with you.

 

INTRODUCTION

You are deciding if you would like to volunteer for a medical research study. You must read and sign this form before you agree to take part in this study.  This form will give you more information about this study.    Please ask as many questions as you need to before you decide if you want to be in the study.  Do not sign this form if you have any questions that have not been answered.

The investigator is the sponsor, and is paying for this study. 
 
You must be honest with the investigator about your health history or you may harm yourself by participating in this study.


PURPOSE OF THE STUDY

The purpose of this study is to understand if GAINSWave Shock Therapy helps with erectile dysfunction. This study involves questionnaires about your experience when using an investigationalmedical device for erectile dysfunction. "Investigational" means the medical device being tested is not approved by the U.S. Food and Drug Administration. If you qualify for the study, you will be completing in GAINSWave Shock Therapy.

HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY

The study will last 365 days. About 3000 men ages 30 through 80, are expected to be in this study.
 

TO BE IN THIS STUDY
 
You cannot be in this study if you are in another research study or if you have been in any other research study in the last 30 days. 
 

COSTS TO BEING IN THE STUDY

Participation requires undergoing self-funded Shockwave Therapy; neither the study team nor the Sponsor will be able to fund treatment for study participants.


Subject Responsibilities:

While participating in this research study, you will need to:

·   Have a Shock Wave Therapy plan for the treatment of erectile dysfunction. A Shock Wave Therapy plan is developed by the study doctor and describes how often you receive Shock Wave Therapy.

·   Be willing and able to follow the study directions and procedures

·   Tell the study staff about any side effects or problems

·   Ask questions as you think of them

·   Tell the investigator or the study staff if you change your mind about staying in the study.

·   Complete your questionnaires at Month 3, 6, 9, and 12.
 

WHAT WILL HAPPEN DURING THE STUDY

Screening:

Before the study starts, you will be asked to sign this consent form, give your health history, and tell study staff if you take any over-the-counter or prescription medicines, vitamins or herbs.

The investigator will do some tests to find out if you can be in the study. These tests include:

·    Physical exam, including vital signs (blood pressure, temperature, heart and breathing rates), height and weight 

·   Capture Medical History

 
Procedure:

In order to participate in this study, you must be receiving shock wave therapy to treat erectile dysfunction.  The study doctor can discuss the procedure with you in more detail, but here is a brief overview:

Shock wave therapy requires that you undress from the waist down.  If you desire, your penis will be numbed with an anesthetic applied to the skin. The study doctor can discuss this and other ways to numb your penis if needed.  The shock waves are administered via a shock wave applicator, which is applied to the penis.  The study doctor will decide on the best spot to put the shock wave applicator on your penis. After the procedure you will dress and can leave immediately.  The numbing medicine wears off in a couple hours and you are free to engage in intercourse that night.


POSSIBLE SIDE EFFECTS AND RISKS

If you do not understand what any of these side effects mean, please ask the investigator or study staff to explain these terms to you. 

Because this device/procedure is investigational, all of its side effects may not be known.  There may be rare and unknown side effects. Some of these may be life threatening.

You must tell the investigator or study staff about all side effects that you have. If you are not honest about your side effects, you may harm yourself by staying in this study.

The majority of side effects are reported to occur within 2 days of treatment.  Below is a list of rare side effects of Shockwave Therapy.

·   Redness

·   Swelling

·   Pain

·   Hematoma (a bruise filled with blood)

·   Petechiae (small purple spots on the skin from broken blood vessels)

·   Skin lesions if you have had cortisone therapy before
CONFIDENTIALITY

Your records of being in this study will be kept private except when ordered by law. The following people will have access to your study records:

·   The investigator

·   Sponsor company or research institution [including monitor(s) and auditor(s)]

·   IntegReview IRB

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.

The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If the study results are presented at meetings or printed in publications, your name will not be used.

 
IN CASE OF STUDY RELATED INJURY

No compensation or payment for treatments is offered by either the site or the sponsor.

Please be aware that some insurance plans may not pay for research-related injuries.  You should contact your insurance company for more information.
 

LEGAL RIGHTS 

You will not lose any of your legal rights by signing this consent form.

 
CONTACT INFORMATION

If you have questions, concerns, or complaints about this study or to report a study related injury, contact:

 Judson M. Brandeis, M.D.
(925) 255-7867 daytime and after hours number of the investigator
research@brandeismd.com

If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact IntegReview.  IntegReview is a group of people that has reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies.  IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

 
                    Mailing Address: OR Email Address:
Chairperson
IntegReview IRB
3815 S. Capital of Texas Highway
Suite 320
Austin, Texas 78704
integreview@integreview.com
 

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:
 
512-326-3001 or
toll free at 1-877-562-1589
between 8 a.m. and 5 p.m. Central Time


IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study.  You must consider the information in this consent form for yourself and decide if you want to be in this study.
 

PAYMENT FOR BEING IN THE STUDY


You will not be paid for being in this study.
VOLUNTEERING TO BE IN THE STUDY
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not want to be in this study or you may leave the study at any time without penalty or loss of benefits to which you are otherwise entitled. 

BrandeisMD may decide to terminate the study.

 If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to have some end of study evaluations or tests.  If information generated from this study is published or presented, your identity will not be revealed.  If you leave the study, no more information about you will be collected for this study.  However, all of the information you gave us before you left the study will still be used.
 

NEW FINDINGS
 
If there is new information or any significant new findings that could relate to your willingness to continue participation we will tell you.  You can then decide if you still want to be in the study. 
 

SUBJECT’S BILL OF RIGHTS

You will be given a separate copy of the California Experimental Research Subject’s Bill of Rights.  If you have not received a copy of this document, please notify study staff.


AGREEMENT TO BE IN THE STUDY

This consent form contains important information to help you decide if you want to be in the study.  If you have any questions that are not answered in this consent form, ask one of the study staff.

Please answer YES or NO to the following questions:

Question Title

* 1. Is this document in a language you understand?

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* 2. Do you understand the information in this consent form?

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* 3. Have you been given enough time to ask questions and talk about the study?

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* 4. Have all of your questions been answered to your satisfaction?

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* 5. Do you think you received enough information about the study?

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* 6. Do you volunteer to be in this study of your own free will and without being pressured by the investigator or study staff?

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* 7. Do you know that you can leave the study at any time without giving a reason and without affecting your health care?

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* 8. Enter your name to digitally sign this consent form:

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