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.
Take the pre-screening questionnaire to see if you might qualify and to be connected directly with a participating spine center in your area.
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 may elect to be contacted by a representative from DiscGenics, who will confirm your continued interest in the study, answer any questions you may have about what is involved and obtain your permission to share your information with the IDCT trial site in your area.
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.
These criteria include (but are not limited to) having early to moderate, symptomatic, single-level DDD from L3-S1, no previous lumbar spine surgery, no radiculopathy (pinched nerve) or leg pain, and no comorbidities, such as tumors, fibromyalgia, systemic disease, osteoarthritis or chronic opioid usage.
For a complete list of inclusion and exclusion criteria, please visit: https://clinicaltrials.gov/ct2/show/NCT03347708.
Additionally, the IDCT trial is being conducted at 14 sites in 12 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.