The Chronic Low Back Pain Clinical Study is currently being conducted at treatment sites throughout the U.S. The purpose of the Study is to evaluate the Intracept Procedure, a minimally invasive procedure for the relief of chronic low back pain.
Chronic Low Back Pain Clinical Study Details
As part of the Study you will receive the Intracept Procedure. If you qualify and choose to join the Study, you will receive all Study-related care at no cost.
Do I Qualify?
In order to be eligible to participate in the Study and receive the Intracept Procedure, you must meet specific study criteria. These criteria are carefully designed to include those patients who are the best possible candidates for the Study. To see if you might qualify for the Study, please take a moment to complete the pre-screening questionnaire.
Frequently Asked Questions
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. The Chronic Low Back Pain Clinical Study conforms to the rules set by the FDA.
During the Intracept Procedure, doctors make a small (3-5mm) incision in the lower back. Following this, a specialized probe is advanced into the vertebrae and positioned at the precise location of the pain-sensing, basivertebral nerve. Once positioned, the Intracept probe uses radiofrequency energy (heat) to disable the basivertebral nerve, rendering it unable to transmit pain signals.
If you choose to take part in the Study, you will be asked to:
- Read and sign the Informed Consent Form
- Undergo the Intracept Procedure
- Schedule and attend all follow-up visits
- Complete specific questionnaires and tests to document your progress
- Quickly report any problems to your physician
If you qualify and choose to join the Study, you will receive all Study-related care at no cost. This includes the Intracept Procedure, as well as all post-treatment care and follow-up. You will receive a small payment upon completion of certain Study visits.
As with all clinical trials, your participation is voluntary, and refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled, and you may discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.
The company sponsoring this Study is Relievant Medsystems, Inc., headquartered in Sunnyvale, CA. Relievant Medsystems is a medical device company dedicated to developing minimally invasive technologies for the treatment of chronic low back pain.
To see if you might qualify for the Clinical Study, please take a moment to complete the pre-screening questionnaire.