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Discogen for Low Back Pain

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 2026 → Dec 31, 2026
See other at-risk trials from Columbia University

Record History

  1. Primary completion pushed from Aug 2026 to Dec 31, 2026 Completion date: Aug 2027 to Aug 30, 2027 · Eligibility criteria expanded, about 23 words · Secondary endpoints: details revised at 2 of 2 entries · 2 more Show 5 more changesShow less
    • Completion date: Aug 2027 to Aug 30, 2027
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 7 words
    • Publications: details revised at 2 of 3 entries
  2. Primary completion date: Mar 15, 2026 to Aug 2026 Completion date: Mar 1, 2027 to Aug 2027v5 Show 1 more changeShow less
    • Completion date: Mar 1, 2027 to Aug 2027
  3. Enrollment target: 40 to 5 Publications: details revised at 3 of 3 entriesv4 Show 1 more changeShow less
    • Publications: details revised at 3 of 3 entries
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 1, 2024 to Mar 15, 2025 · Primary completion date: Dec 15, 2025 to Mar 15, 2026 · Completion date: Jan 1, 2026 to Mar 1, 2027 · 2 morev3 Show 5 more changesShow less
    • Start date: Dec 1, 2024 to Mar 15, 2025
    • Primary completion date: Dec 15, 2025 to Mar 15, 2026
    • Completion date: Jan 1, 2026 to Mar 1, 2027
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  5. Start date: Oct 1, 2024 to Dec 1, 2024 Primary completion date: Oct 15, 2025 to Dec 15, 2025 · Secondary endpoints: details revised at 1 of 2 entriesv2 Show 2 more changesShow less
    • Primary completion date: Oct 15, 2025 to Dec 15, 2025
    • Secondary endpoints: details revised at 1 of 2 entries
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.
Trial Details
NCT Number NCT06611397
Lead Sponsor Columbia University
Collaborators: Discogen
Conditions Disc Herniation
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov