Varicose Vein Study Frequently Asked Questions
 

What is the purpose of the study? (top)
This clinical research study is designed to determine the safety and effectiveness of an investigational drug and non-surgical procedure for the treatment of varicose veins.

How do you define Varicose Veins? (top)
Varicose veins are veins that become abnormally swollen and bulge above the skin’s surface. They are usually bluish in color, and may have a twisted, worm-like appearance. They may be uncomfortable or even painful, and can cause swelling of the feet and ankles. They differ from spider veins or thread veins, which are generally reddish and do not swell or visibly bulge.

Will the completion of the pre-qualification screener guarantee my participation in the study? (top)
No. Only the physician at the study site can determine if you are medically qualified to participate in the study. The pre-screening survey will ask you several questions about your health and medical history to determine if you pre-qualify for the study.

What company is sponsoring the study? (top)
This study is sponsored by BTG International Limited.

Are there any side effects to the study treatment? (top)
The study procedure itself is not uncomfortable. Following the study procedure you may experience leg discomfort or bruising, as well as other possible side effects. If you pre-qualify for the study and are referred to a study site, the study staff will be happy to review that information with you.

How will I be compensated for my participation in the study? (top)
You will receive the study treatment and all study related health care at no charge to you. The study site will be able to answer your questions regarding compensation for travel and parking.

What is a clinical study? (top)
Clinical studies are designed to test the safety and effectiveness of investigational medications and procedures. All clinical studies are conducted under the direction of healthcare professionals. These healthcare professionals are researchers and must comply with guidelines and safeguards to protect study participants. In addition, an institutional review board (IRB) must approve every study. An IRB is an independent committee that is typically made up of physicians, statisticians, community advocates, and others to help ensure that a study is ethical and that your rights as a study participant are protected.

With these controls in place, the safety and the needs of the subjects are put first. If you are referred to a site, you will be educated about possible risks and benefits to ensure that your decision to participate is well informed. You may decide at any time to stop participating in a clinical study without any loss of benefit to which you would otherwise be entitled.

Why should I participate in a clinical research study? (top)
By participating in a clinical research study, you are contributing to medical research that may help others. You may be assisting researchers answer questions about possible treatments that may one day be available to people throughout the world.

Who is conducting this clinical study? (top)
It is being conducted by qualified researchers who are licensed physicians and medical specialists across the country.

Would participation in this clinical study cost me anything? (top)
No. If you qualify for this study, all study-related medical care, study treatment, and monitoring that you receive during your participation is provided at no charge to you.

Where are the clinical study sites? (top)
There are a number of study sites located throughout the United States. If you provide a zip code and pre-qualify for the study, we will be able to determine if there is a site in your area.

How often would I have to go to the study site? (top)
You would need to go to up to nine site visits over the course of about 6 months.

What would I expect when I go for the first visit? (top)
At your first visit to the research site, the study site personnel will explain the risks and benefits of this research study and ask you to review an informed consent document. This document provides you with a detailed description of the research study. If you decide to participate, your signature on the informed consent document confirms your understanding of the risks and benefits of the study, as well as your willingness to participate. You may also review the informed consent with your primary care physician, if this makes you feel more comfortable. Participation is entirely voluntary and you may withdraw at any time during the study.

Should you choose to participate, you will be asked questions about your medical history along with any medications that you may have taken or are taking. In addition, you will have a study-related medical exam and undergo other study health-related tests in order to determine if you qualify to participate.

When will I know if I qualify for this study? (top)
The questions in the pre-screening survey are used only as a preliminary screening. If you pre-qualify today based on your answers to this screener, a member of the study team will contact you to come in for a screening visit. At that time they will determine if you qualify for this research study based on the results from your screening visit.

Does my primary care physician have to give his or her permission for me to participate in this clinical study? (top)
No. However, you are encouraged to let your doctor know that you plan to participate in this clinical study. Your doctor, with your permission, can contact the clinical study doctor for more information at any time.

What should I tell my family doctor/internist/primary care physician? (top)
You are encouraged to tell your doctor that you are considering becoming a participant in a clinical study for varicose veins. Your doctor also needs to know that for the duration of the study, the medical researchers at the study site will be evaluating you. The site staff will not take the place of your doctor, they will work with them. With your permission, a doctor at the study site will be happy to discuss the treatment with your doctor.

What are the risks for participating in this study? (top)
There may be side effects associated with this study treatment, and there is no guarantee that you will benefit by taking part in this clinical research study. If you pre-qualify for this study based on your answers to the pre-screening survey, the staff at the site where you would receive care will discuss the risks and benefits in detail with you.

I am worried about confidentiality. Who will have access to my name and the information you are collecting? (top)
Any information you provide will not be shared with anyone who is not directly associated with this study without your permission or except as required by law.

Why do you need my date of birth? (top)
Your date of birth will be used to determine if you pre-qualify for the study. Participants in this study must fall within a specific age group.

Why do you need my contact information? (top)
If you pre-qualify for the study, your contact information will be provided to the study site. The site will use this information to contact you to schedule a time for a thorough screening to further determine if you qualify to participate in this study.

Is this study treatment FDA approved? (top)
No. The study treatment is still being investigated in clinical trials like this one. The current trial will provide the study sponsor and the FDA with a more thorough understanding of the drug's effectiveness, benefits, safety, and range of adverse events.

What is an informed consent document? (top)
This is a document that provides you with a detailed description of the clinical study. Your signature on the informed consent document confirms your understanding of the risks and benefits of the study as well as your willingness to participate. Participation is entirely voluntary and you may withdraw at any time. Signing an informed consent document does not take away any of your legal rights.