The INTRACEPT 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.
INTRACEPT Clinical Study Details
As part of the INTRACEPT Clinical Study, you will be randomly assigned (by computer) to the treatment group or the control group. If you are selected for the control group, you will be offered the opportunity to undergo the Intracept Procedure after all Study follow-up visits are complete, if you still meet the Study criteria. If you qualify and choose to join the INTRACEPT Clinical Study, you will receive all Study-related care at no cost.
Do I Qualify?
In order to be eligible to participate in the INTRACEPT Clinical 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 INTRACEPT Clinical Study. To see if you might qualify for the INTRACEPT Clinical 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 INTRACEPT 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.
The purpose of the INTRACEPT Clinical Study is to determine whether patients undergoing the Intracept Procedure will experience greater relief of their back pain than patients in the control group. However, patients originally assigned to the control group, and still meet the Study criteria, will have the opportunity to undergo the Intracept Procedure at no cost to them after all Study follow-up visits have been completed.
If you choose to take part in the INTRACEPT Clinical Study, you will be asked to:
- Read and sign the Informed Consent Form
- Undergo the Intracept Procedure or participate in the control group
- 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 INTRACEPT Clinical 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 INTRACEPT Clinical Study, please take a moment to complete the pre-screening questionnaire.