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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120024 / PAS002 |
| Date Original Protocol Accepted |
06/11/2015
|
| Date Current Protocol Accepted |
01/31/2020
|
| Study Name |
Enhanced Safety Surveillance Study
|
| Device Name |
ACTIVL ARTIFICIAL DISC
|
| Clinical Trial Number(s) |
NCT00589797
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The ESS is an unmasked, uncontrolled surveillance system of the activL for 10 years following PMA approval. Data will be collected through surgeon surveys, reporting of adverse events, and Medical Device Reports (MDRs) that may result from complaints received at Aesculap or may be filed with FDAs adverse event reporting database (Manufacturers and User Facility Device Experience, MAUDE) by a hospital or surgeon, and literature review.
|
| Study Population |
Surgeons that use the device will be asked about their experience when treating patients with the activL device.
|
| Sample Size |
N/A
|
| Key Study Endpoints |
Information related to outcomes, subsequent surgical interventions (SSIs), additional pain management procedures, device ease of use, device satisfaction, device malfunction, device removal, and/or other serious device-related adverse events.
Explant analysis (will be reported separately)
Supporting documentation for all complaints and MDRs reported for the activL implants and instruments
|
| Follow-up Visits and Length of Follow-up |
There is no patient follow-up. The surveillance system survey will be conducted annually for 10 years .
|
| Interim or Final Data Summary |
| Interim Results |
N/A
|
| Actual Number of Patients Enrolled |
N/A
There is no enrollment of patients. All patients who have received this device in the post-market environment, i.e. all patients who are implanted with the device. The intended patient population under general conditions of use in the United States and in the rest of the world.
|
| Actual Number of Sites Enrolled |
N/A
Annual surgeon survey: active collection of surgeon feedback annually to elicit information related to HO, device malfunction, device removal, or other serious device related complications.
|
| Patient Follow-up Rate |
Numbers of sites, IRB approvals and study participants are not available, since this ESS does not include enrollment of sites/patients. There is no enrollment of patients.
|
| Final Safety Findings |
Not evaluated, this is a surveillance study.
|
| Final Effect Findings |
Not evaluated, this is a surveillance study.
|
| Study Strengths & Weaknesses |
The strength of this study is that the data is collected from real world usage of this device and used by practitioners with a variety of experience and familiarity with the device. The weakness is that this study is highly dependent on surgeon feedback, so the response rate may be low.
|
| Recommendations for Labeling Changes |
N/A
Labeling was updated with 7-year follow-up data, and no new issues or concerns have been found since that time.
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