Condition: Degenerative Disc Disease · Sponsor: DiscGenics, Inc.
This is a Phase III, randomized, double-blinded, Sham-controlled, multi-center study in subjects with single-level, symptomatic lumbar (L3- S1) intervertebral disc degeneration. The study will have a 52-week primary period followed by 52 week Follow-up Period (total of 104 weeks). The study protocol will be approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and the study will be conducted in accordance with Good Clinical Practice (GCP). All subjects will provide written informed consent prior to Screening. Approximately 162 subjects will be enrolled in the study. Up to 45 days prior to treatment, subjects will be screened for study inclusion, which includes obtaining baseline MRI and X-ray imaging. Imaging results for subjects initially eligible for study participation will be sent to a central imaging vendor for review and confirmation of eligibility, including the number of levels with degeneration. Subjects meeting all inclusion/exclusion criteria will be assigned to the corresponding treatment arm group and subsequently randomized to IDCT or Sham. Randomization will occur approximately 7 to 14 days prior to the scheduled treatment administration date. Overall, 162 subjects will be enrolled and randomized to IDCT or Sham in a 2:1 ratio. * IDCT (n=108) * Sham (n=54)
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Alabama Clinical Therapeutics | Birmingham, Alabama, United States | Recruiting |
| Solaris Research Institute | San Diego, California, United States | Recruiting |
| Source Healthcare | Santa Monica, California, United States | Recruiting |
| International Spine, Pain and Performance Center | Washington D.C., District of Columbia, United States | Recruiting |
| Conquest Research | Orlando, Florida, United States | Recruiting |
| Vantage Clinical Trials | St. Petersburg, Florida, United States | Recruiting |
| Vantage Clinical Trials | Tampa, Florida, United States | Recruiting |
| Injury Care Family Care Research | Boise, Idaho, United States | Terminated |
| Axis Spine Center | Post Falls, Idaho, United States | Recruiting |
| Indiana Spine Group | Carmel, Indiana, United States | Recruiting |
| The Orthopedic Center of St. Louis | St Louis, Missouri, United States | Recruiting |
| Wake Research | Wilmington, North Carolina, United States | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07254806