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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Superion New Enrollment Study


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General
Study Status Progress Inadequate
Application Number P140004 / PAS002
Date Current Protocol Accepted 09/10/2019
Study Name Superion New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, observational post-approval (Conditions of Use) study through 60 months.



The first and primary objective is to evaluate longer term (5 year) Superion® device performance in the ‘actual conditions of use’ population relative to the IDE investigational cohort. A composite clinical success (CCS) endpoint will be used to facilitate this comparison.

A Month 24 composite clinical success (CCS) endpoint similar to that used in the IDE trial will be employed for this comparison.

The third objective is to compare clinical status of patients implanted with the Superion® device relative to surgical decompression two years post operatively. A composite clinical success (CCS) endpoint will be used for this comparison.

Study Population Description Subjects suffering from moderate symptoms of neurogenic claudication secondary to a confirmed diagnosis of moderate LSS at one or two contiguous levels from L1 to L5 who meet all inclusion/exclusion criteria. Subjects will be either randomized to the Vertiflex or ACDF.
Sample Size 214 subjects (174 Superion®) at up to 25 sites



Data Collection Primary effectiveness endpoint is a composite of safety and effectiveness. Subjects will be evaluated for success at 24 months, compared to the success of Superion® IDS subjects in the IDE trial at 24 months. The study endpoint is the non-inferiority of overall subject success at the 24-month follow-up visit vs. the 24-month success in the IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit:

1. Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ

• = 0.5-point improvement in physical function

• = 0.5-point improvement in symptom severity

• = 2.5 point on patient satisfaction domain

2. No reoperations, removals, revisions, or supplemental fixation at the index level(s)

3. No major implant or procedure-related complications

• no dislodgement, migration, or device deformation

• no new or persistent worsened neurological deficit at the index level



The following endpoints will be evaluated at 24 months and annually thereafter through end of study.

• Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring =3 on a 4-point scale

• Change in opioid medication use for Lumbar Spinal Stenosis (LSS) from baseline

• Proportion of Subjects with improvement of 20mm in Visual Analog Scale (VAS) for low back and leg pain (on the 100 mm scale) compared to baseline

• Proportion of Subjects with ODI improvement of at least a 15 points compared to baseline

• Improvement in quality of life as defined by EQ-5D-5L

• Proportion of subjects with epidural injections, nerve block procedures or rhizotomies at index level, or spinal cord stimulators

• Characterization of spinous process fractures in terms of location, configuration, displacement, angulation and rate of healing.

The following endpoint will be evaluated at 36 months through end of study:

• Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ

o = 0.5-point improvement in physical function

o = 0.5-point improvement in symptom severity

o = 2.5 point on patient satisfaction domain

• No reoperations, removals, revisions, or supplemental fixation at the index level(s)
Follow-up Visits and Length of Follow-up Study events occur at the following time points:

• Screening/Baseline Visit

• Surgical Treatment- Day 0 (up to 30 days after confirming Eligibility requirements)

• Discharge (0-7 days post IDS implant)

• 6-Week Visit (42 days ±14 days post IDS implant)

• 6-Month visit (180 days ±60 days post IDS implant)

• 12-Month Visit (365 days ±60 days post IDS implant)

• 24-Month Visit (730 days ±60 days post IDS implant)

• 36-Month Visit (1,090 days ±120 days post IDS implant)

• 46-Month Visit (1,460 days ±120 days post IDS implant)

• 60-Month Visit (1,825 days ±120 days post IDS implant)


Superion New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 05/19/2016 05/20/2016 Overdue/Received
two year report 05/19/2017 05/19/2017 On Time
three year report 05/19/2018 05/21/2018 Overdue/Received
four year report 05/19/2019 05/20/2019 Overdue/Received
five year report 05/18/2020    


Contact Us

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

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