Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Status: Enrolling_by_invitation
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
• Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study
Locations
United States
North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte
Texas
Texas Back Institute
Plano
Time Frame
Start Date: 2023-01-18
Completion Date: 2029-05-10
Participants
Target number of participants: 158
Treatments
Simplify Disc
Extended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378.
Related Therapeutic Areas
Sponsors
Leads: NuVasive