|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110039 / PAS001 |
| Date Original Protocol Accepted |
10/18/2012
|
| Date Current Protocol Accepted |
03/15/2013
|
| Study Name |
New Enrollment Study
|
| Device Name |
EXABLATE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study design is multi-center prospective cohort. .
|
| Study Population |
The sample size is 70 patients. Sample size and power calculations are provided in the protocol. The study population will be comprised of patients inside the United States who sign an informed consent and receive the device in the post-market environment.
|
| Sample Size |
The sample size is 70 patients. Sample size and power calculations are provided in the protocol. The study population will be comprised of patients inside the United States who sign an informed consent and receive the device in the post-market environment.
|
| Key Study Endpoints |
Study endpoints include pain response, medication use and quality of life.
|
| Follow-up Visits and Length of Follow-up |
Patients will undergo clinical examination at the time of enrollment and one month and 3 months
post-treatment. The total length of follow-up is three months.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
32
|
| Actual Number of Sites Enrolled |
10
|
| Patient Follow-up Rate |
97% at 1 week, 90% at 1 month, 79% at 2 month, 81% at 3 month
|
| Final Safety Findings |
Out of 32 subjects treated, seven adverse events have been reported (five mild, one moderate and one severe). All adverse events are expected procedure finding. The safety profile is the same as previously reported in the PMA #P110039 as expected. Most events were mild and can be managed with adequate anesthesia (sonication pain) or treatment technique (e.g., skin burn). No new safety or subject protection concerns are raised by the reported information.
|
| Final Effect Findings |
The proportion of responders, NRS and BPI pain scores and percent change from baseline are presented and compared to the pivotal trial US Cohort. The findings are as expected and consistent with the pivotal trial.
|
| Study Strengths & Weaknesses |
Strength: The goal of the PAS study has been met to show that the results from pivotal trial have been duplicated in a separate study. No new safety or subject protection concerns are raised. Weakness: Small sample size due to difficulty in patient enrollment.
|
| Recommendations for Labeling Changes |
No Labeling change recommended
|
