1. What is the purpose of a clinical study?
2. Can I have the Intracept Procedure without joining in the SMART Clinical Study?
3. Are there any costs involved in the SMART Clinical Study?
4. Where is the SMART Clinical Study being conducted?
5. Who is the company responsible for the SMART Clinical Study?
6. What if I join the study and decide I do not want to participate anymore?
7. When will I know if I am eligible?
8. What if I have other questions about the SMART Clinical Study that are not addressed on this website?

1. What is the purpose of a clinical study?

The purpose of a clinical study (also called a “clinical trial” or “research trial”) is to examine treatment options for specific health conditions. Although there are many types of clinical studies, all must conform to strict rules set by the U.S. Food and Drug Administration (FDA). These rules help protect the rights and safety of those who volunteer to take part in clinical research studies.

2. Can I have the Intracept Procedure without joining in the SMART Clinical Study?

No, the Intracept Procedure is investigational and is currently only available through the SMART Clinical Study.

3. Are there any costs involved in the SMART Clinical Study?

If you qualify and choose to join the SMART Clinical Study, you will receive all study-related care at no cost. This includes the Intracept Procedure, as well as all post-procedure care and follow-up. You will also be reimbursed for your time and travel.

4. Where is the SMART Clinical Study being conducted?

The SMART Clinical Study is being conducted at several specialized spine centers throughout the U.S. To find a center near you, please visit the pre-screening questionnaire. The questionnaire will ask for your zip code and then search for SMART study locations in your area.

5. Who is the company responsible for the SMART Clinical Study?

The company sponsoring this study is Relievant Medsystems, Inc., headquartered in Redwood City, CA. Relievant Medsystems is a medical device company developing minimally invasive technologies for the treatment of chronic low back pain.

6. What if I join the study and decide I do not want to participate anymore?

As with all clinical trials, your participation is completely voluntary and you may leave the study at any time. This will not affect your medical care or relationship with any of your doctors.

7. When will I know if I am eligible?

If you pass the initial pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent directly to the local SMART study location in your area. The Study Coordinator at your local site will then contact you within a couple of days to review your responses and help determine your eligibility.

8. What if I have other questions about the SMART Clinical Study that are not addressed
on this website?

To see if you might qualify for the SMART Clinical Study, and to be referred to the local treatment center in your area, please take a moment to complete the pre-screening questionnaire. If you pass the pre-screening questionnaire, you will be able to enter your name and contact information, which will be sent to the local SMART study location in your area. The Study Coordinator at your local site will then contact you within a couple of days to answer any additional questions you might have about the SMART Clinical Study.

 

Intracept is a trademark of Relievant Medsystems, Inc.
Caution: The Intracept Procedure is an investigational device and is limited by United States law to investigational use.
© 2011 Relievant Medsystems, Inc. All rights reserved.