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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continued Follow-up Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P250042 / PAS001
Date Original Protocol Accepted 09/22/2026
Date Current Protocol Accepted 09/22/2026
Study Name Continued Follow-up Study
Device Name BAGUERA®C Cervical Disc Prosthesis
Clinical Trial Number(s) NCT04520776 NCT04564885 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of the BAGUERA® C subjects to evaluate the 5-year long-term safety and effectiveness for single- and two contiguous-level total disc replacement
Study Population Subjects implanted with the BAGUERA® C during the IDE Studies (G200182 and G200239)
Sample Size Number of subjects: 178 for single level study and 193 for two contiguous-level
Assumptions for sample size estimation: Continued study participation from subjects available from the modified intent to treat (mITT) Set who were enrolled in the pivotal study and were not a CCS failure at Month 24.
Number of sites: 23
Sites location: United States
Key Study Endpoints Safety Endpoints
Primary:
- No secondary surgical intervention defined as revision, removal, reoperation, or supplemental fixation at the index level(s)
- No serious adverse event(s) confirmed as definitely related to the device or index procedure (as determined by the CEC)
Secondary:
-Evaluation of the incidence and severity of complications and adverse reactions associated with the treatment
Effectiveness Endpoints
Primary:
-Improvement from baseline in pain and function, as measured through the Neck Disability Index (NDI), of at least 15 percentage points
-Maintenance or improvement in neurological status at 60 months compared to baseline (as determined by the CEC)
Secondary:
- Left and right arm pain 100 mm Visual Analogue Scale (VAS) (an improvement in pain of at least 20 mm on the VAS is considered clinically significant)
- Neck pain 100 mm Visual Analogue Scale (VAS) (an improvement in pain of at least 20 mm on the VAS is considered clinically significant)
- Health Related Quality of Life (SF-12 v 2) Physical Component Summary (PCS) and Mental Component Summary (MCS)
- Patient Satisfaction
- Dysphagia Handicap Index
- Odom Criteria to measure surgical success (determined by the implanting surgeon)
Follow-up Visits and Length of Follow-up Annually through 60 months after surgery


Continued Follow-up Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/08/2027    
1 year report 08/10/2027    
2 year report 08/09/2028    
final report 08/30/2029    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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