Do I qualify for participation in the IDCT trial?

If you have been diagnosed with or believe you have degenerative disc disease in your lower back, you may be interested in the IDCT trial.

How do I get pre-screened for the IDCT trial?

Click here to take an online pre-screening questionnaire.

The questionnaire will help determine if you meet the key inclusion criteria for the IDCT trial. However, please note that completing the questionnaire does NOT obligate you to participate in the study and only your local study site can determine whether or not you may be eligible to join.

If I qualify, what are the next steps?

If your responses meet the preliminary criteria for the study, you'll have the option to share your contact information with DiscGenics. If there's an IDCT trial site in your area, DiscGenics will pass your information to that site, and the site will contact you when recruitment begins.

What are some reasons I may not qualify for the IDCT trial?

Prior to beginning the IDCT trial, DiscGenics worked closely with the U.S. Food and Drug Administration (FDA) to define a set list of enrollment criteria that would enable us to most effectively and efficiently evaluate the safety and preliminary efficacy of IDCT for the treatment of degenerative disc disease. This requires us to follow very specific screening guidelines to ensure that the subjects enrolled in our study meet the criteria we agreed upon with the FDA. 

Some of these criteria include (but are not limited to) adults 18 and 75 years old who have ongoing lower back pain (for at least 6 months) caused by one degenerated disc in their lower back (between the discs L3 to S1) and have tried other treatments like medicine and physical therapy without success. They also need to be healthy enough to participate and cannot join if they have certain other types of back problems (like those caused from nerve pain have degeneration in more than one disc), infections, serious illnesses, past spine surgeries, or conditions that make the procedure unsafe.

For a complete list of inclusion and exclusion criteria, please visit clinicaltrials.gov. 

Additionally, the IDCT trial is being conducted at 30-35 sites across the United States. Potential subjects who may otherwise qualify for the trial but are deemed to live too far away from one of the clinical study sites to complete all in-person assessments over the course of the 2-year study may also be disqualified based on geographic distance.