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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P860004 S056/ PAS001 |
| Date Original Protocol Accepted |
09/12/2003
|
| Date Current Protocol Accepted |
09/12/2003
|
| Study Name |
Synchromed II
|
| Device Name |
SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is a 12-month, multi-center, single arm prospective cohort study. All subjects in the study receive the device.
|
| Study Population |
Study population: Patients at least 18 years old receiving the infusion system for the treatment of chronic, intractable pain or severe spasticity of spinal or cerebral origin and those receiving an initial pump or replacement pump. Indication for use: The SynchroMed II infusion system is an implantable, programmable drug delivery system used to treat pain, spasticity, and cancer. It is indicated for: 1) Chronic intraspinal (intrathecal or epidural) infusion of sterile, preservative-free morphine sulfate for chronic, intractable pain of malignant and/or benign origin; 2) Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain; 3) Chronic intrathecal infusion of Lioresa Intrathecal (baclofen injection) for severe spasticity of spinal or cerebral origin; and 4) Chronic intravascular infusion of methotrexate and floxuridine for the treatment of cancer (not included in this study).
|
| Sample Size |
100 subjects, 13 sites
|
| Key Study Endpoints |
Primary endpoint: comparison of observed refill measurements to calculated volume dispensed for patients with at least 2 refills during the first six months. Secondary endpoint: descriptive evaluation of all adverse events and technical observations through 12 months post-implant.
|
| Follow-up Visits and Length of Follow-up |
Data were to be collected at the following visits: baseline evaluation, system implant, 1, 6, and 12 months post-implant, interim refill visits, and visits for adverse events.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
82 patients enrolled, 80 implanted
|
| Actual Number of Sites Enrolled |
9
|
| Patient Follow-up Rate |
85%
|
| Final Safety Findings |
All the subjects included in the primary analysis had accuracy ratios within the prespecified interval. Thirty-eight subjects experienced 58 device-related events, the most frequent were: implant site effusion (n=16 events), lumbar puncture headache (n=8), catheter dislodgement (n=5), and implant site inflammation (n=4). Three events were treated with device explant. The probability of pump survival at 12 months was 95.8%.
|
| Study Strengths & Weaknesses |
Strengths: The study assessed known potential serious adverse event through capturing dispensing. Weaknesses: The study did not capture over- and under-infusions resulting in toxicity/overdose or decreased therapeutic responses as potentially device-related events. The study did not account for differences in pump function with approved, non-approved, or compounded drugs. The pre-specified interval was wide and included both very high and very low values.
|
| Recommendations for Labeling Changes |
There were no recomendations were made for labeling changes.
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