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|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P010039 / PAS001 |
| Date Original Protocol Accepted |
04/03/2003
|
| Date Current Protocol Accepted |
09/27/2005
|
| Study Name |
Sonocur
|
| Device Name |
SIEMENS SONOCUR BASIC SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The sponsor originally agreed to perform a multi-center, non-randomized cohort study to examine device performance that called for a patient population of 223. The primary objective of the post-approval study is to assess the neurological status of the treated upper extremity secondary to extracorporeal shock wave therapy treatment using the Siemens SONOCUR Basic system.There are no formal study hypotheses. FDA approved a modified post-approval study protocol in October 2005 that reduced the sample size from 223 to 125 subjects.
|
| Study Population |
The deive is indicated as an alternative for the treatment of chronic lateral epicondylitis (commonly referred to as tennis elbow) for patients with symptoms of chronic lateral epicondylitis for 6
months or more and a history of unsuccessful conservative treatments. The study population consisted of subjects with chronic tennis elbow. Patients who present for routine clinical therapy for chronic lateral epicondylitis are eligible to participate. Patients who present with abnormal (diminished or absent) sensory function and abnormal (nonfunction) motor function in the hand (treatment side) at the baseline visit were not be included in the study.
|
| Sample Size |
223 subjects; however FDA approved a protocol modification to reduce sample size to 125 subjects
|
| Key Study Endpoints |
Subject evaluation at the 12 week visit will include an assessment of motor function, sensory test, pain intensity using the Thomsen provocation test, adverse event evaluation and a limited physical examination. The primary efficacy endpoint was at least a 50% reduction from baseline to week 12 post-treatment in the pain VAS during resisted wrist extension. The secondary efficacy endpoint was an improvement from baseline to Week 12 post-treatment in the patient's mean UEFS.
|
| Follow-up Visits and Length of Follow-up |
12 weeks after the last extracorporeal shock
|
| Interim or Final Data Summary |
| Interim Results |
Study Terminated. See Final Study Results
|
| Actual Number of Patients Enrolled |
2 subjects
|
| Actual Number of Sites Enrolled |
At the time study was terminated the 2 enrolled subjects had not completed the 12-week follow-up
|
| Patient Follow-up Rate |
0
|
| Final Safety Findings |
No data available
|
| Study Strengths & Weaknesses |
The study was only able to enroll 2 subjects.
|
| Recommendations for Labeling Changes |
None
|
