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NCT04980378 · ClinicalTrials.gov registry record
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
A clinical trial, sponsored by NuVasive.
- Completed
- Registry status
- 291
- Enrollment target
NCT04980378: Completed study, sponsored by NuVasive.
NCT04980378 is a clinical trial that has completed, run by NuVasive. The registered enrollment target is 291 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04980378 has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- 291 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
Primary Outcome
Individual success for Simplify Disc was defined as follows: * Neck Disability Index (NDI) score improvement of at least 15 points from pre-operative; * Maintenance or improvement in neurological status; * No serious adverse event classified as implant associated or implant/surgical procedure associated; and * No additional surgical procedure classified as a "failure."
Interventions
- DEVICE Simplify Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2024-01-24 |
What the finished NCT04980378 record still lists
NCT04980378 is an observational study that tracks outcomes without assigning an intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Simplify Disc is the first listed.
NCT04980378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04980378 about?
NCT04980378 is a clinical study titled "Post Approval Study Protocol for the Two Level 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
What is the current status of trial NCT04980378?
This trial is currently completed. The enrollment target is 291 participants. The study started on 2021-08-01. Estimated completion is 2024-01-24.
What interventions are being tested in trial NCT04980378?
The interventions under investigation include: Simplify Disc (DEVICE).
Who is sponsoring clinical trial NCT04980378?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
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