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NCT04630626 · ClinicalTrials.gov registry record · NA
Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
A NA study, sponsored by NuVasive.
- Completed
- Registry status
- NA
- Development phase
- 145
- Enrollment target
NCT04630626: Completed NA study, sponsored by NuVasive.
NCT04630626 is a NA study that has completed, run by NuVasive. The registered enrollment target is 145 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630626, a NA study, has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
Study Summary
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.
Primary Outcome
Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows: * Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and * No device failures by Month 60, and * No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60.
Interventions
- DEVICE Simplify Disc
- OTHER ACDF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-04-23 |
| Phase | NA |
What the finished NCT04630626 record still lists
NCT04630626 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Simplify Disc is the first listed.
NCT04630626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04630626 about?
NCT04630626 is a clinical study titled "Post-Approval Study Protocol for the Simplify Cervical Artificial Disc". This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.
What is the current status of trial NCT04630626?
This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2021-01-01. Estimated completion is 2023-04-23.
What interventions are being tested in trial NCT04630626?
The interventions under investigation include: Simplify Disc (DEVICE), ACDF (OTHER).
Who is sponsoring clinical trial NCT04630626?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04630626's enrollment target sits among peer trials
145 705th of 2000 higher than 1,295 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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