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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020031 / PAS001 |
| Date Original Protocol Accepted |
09/23/2003
|
| Date Current Protocol Accepted |
09/23/2003
|
| Study Name |
MEA PAS
|
| Device Name |
MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continue to follow all subjects from the multi-center study for a period of three years from the time of treatment. The patient follow-up reports will be submitted annually as PMA reports. When a full three-year followup report is submitted, FDA was to determine if continued follow-up of these study subjects is required.
|
| Study Population |
Study population is as per device indication. This device is indicated for ablation of the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
|
| Sample Size |
215 device group; 107 control
|
| Key Study Endpoints |
Data collected should include: need for hysterectomy or repeat ablation; assessment of patient's menstruation pattern; adverse events and/or complications; Quality of Life information; patient's pregnancy and contraception status; and diagnosis of malignancy of the uterus.
|
| Follow-up Visits and Length of Follow-up |
3 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
141 device group; 74 control group
|
| Actual Number of Sites Enrolled |
Not mentioned
|
| Patient Follow-up Rate |
66% device group; 69% control group
|
| Final Safety Findings |
No significant difference in amenorrhea rates at 3 years between the microwave endometrial ablation and rollerball endometrial ablation groups was observed. Patient acceptance and satisfaction at 3 years were very high, in excess of 98%, for both treatment arms. No significant difference in the quality of life, based on SF-36 scores was observed between the two treatment arms. No pregnancies were reported among the study participants, an observation of note given that pregnancy has been reported in the literature among endometrial ablation recipients.
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| Study Strengths & Weaknesses |
The pre-market study was a randomized clinical trial with the patients randomized to microwave endometrial ablation or rollerball endometrial ablation arms. However, the loss to follow-up was appreciable over the three year follow-up period; 33% among the microwave endometrial ablation arm and 31% among the rollerball endometrial ablation arm. Loss to follow-up can introduce bias and limit interpretation of study results.
|
| Recommendations for Labeling Changes |
As per PAS Closing letter: labeling should be revised to reflect the long-term safety and effectiveness data gathered on the MEA System
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