Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01905930 · ClinicalTrials.gov registry record · Phase 3
Post-Approval Clinical Trial of the PCM® Cervical Disc
A Phase 3 study, sponsored by NuVasive.
- Completed
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT01905930 is a Phase 3 study that has completed, run by NuVasive. The registered enrollment target is 494 participants.
The verdict
NCT01905930, a Phase 3 study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the PCM Cervical Disc.
Interventions
- DEVICE Anterior Cervical Discectomy and Fusion (ACDF)
- DEVICE PCM Cervical Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01905930
The ClinicalTrials.gov registry entry for NCT01905930 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 494 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NuVasive, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anterior Cervical Discectomy and Fusion (ACDF) is the first listed.
NCT01905930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01905930 about?
NCT01905930 is a clinical study titled "Post-Approval Clinical Trial of the PCM® Cervical Disc". On October 26, 2012, the FDA granted Premarket Approval (PMA) for the PCM Cervical Disc. PCM Cervical Disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculop...
What is the current status of trial NCT01905930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2013-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01905930?
The interventions under investigation include: Anterior Cervical Discectomy and Fusion (ACDF) (DEVICE), PCM Cervical Disc (DEVICE).
Who is sponsoring clinical trial NCT01905930?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.