Other Clinical Trial - Post Approval Study Protocol for the Two Level

Clinical Trial 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

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04630626` - Post-Approval Study Protocol for the Simplify Cervical Artificial Disc	N/A
	Completed	`NCT03123549` - Investigation of the Two Level Simplify® Cervical Artificial Disc	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT04630626 - Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

N/A

Completed

NCT03123549 - Investigation of the Two Level Simplify® Cervical Artificial Disc

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04980378
Study type	Observational
Source	NuVasive
Contact
Status	Completed
Phase
Start date	August 1, 2021
Completion date	January 24, 2024

Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms