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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000032 S028/ PAS001 |
| Date Original Protocol Accepted |
03/27/2009
|
| Date Current Protocol Accepted |
03/27/2009
|
| Study Name |
Her Option PAS
|
| Device Name |
HER OPTION OFFICE CRYOABLATION THERAPY 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 |
This is a prospective study to continue follow-up of the premarket cohort. As per approval order, the results of the 2 and 3-year follow-up of the study subjects will be provided.
|
| Study Population |
This device is a closed-cycle cryosurgical device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete. The study population is the subjects that were treated premarket.
|
| Sample Size |
All premarket subjects
|
| Follow-up Visits and Length of Follow-up |
3 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
106 women
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
At the end of the three year follow-up 51 participants were followed out of 82 treated (62.2%)
|
| Final Safety Findings |
Of the 82 subjects treated, 54 subjects (65.9%) were free of any treatment-related complications or side-effects. Only 2 (2.4%) subjects experienced serious adverse events related to study treatment. According to the Sponsor, there were no serious unanticipated adverse events within the study population. The Sponsor reported a reduction of pain/cramping and PMS symptoms following treatment , with 10 and 14 subjects reporting moderate to severe symptoms immediately after the intervention and after 12 months respectively. According to Sponsor incident events of bleeding through onto clothing was reported by 95% of subjects at the baseline assessment. At the 12 month visit, only 8% of subjects reported negative impact on quality of life, and bleed-through incidences were reduced to 23% of subjects
|
| Final Effect Findings |
Long term success rates were calculated for the 2-year and 3-year visits and demonstrate a success rate of 56.1% and 54.9% of subjects treated respectively. A percent reduction in menstrual levels from baseline was achieved in 89.4%, 90.9%, and 92.1% of participants after each of the three years of follow-up respectively.
|
| Study Strengths & Weaknesses |
This multicenter study was well planned and conducted to evaluate the effectiveness of this surgical device to treat menorrhagia due to benign causes in women for whom childbearing is complete. The study was conducted at seven sites by gynecology specialists with experience in the device and who were familiar with clinical research. As with any other study, there are limitations that need to be pointed out to have a better understanding of the results. Data from 9 censored patients, due to lack of effectiveness of the device, are excluded from the analysis. If these participants were included in the calculation, the effectiveness is estimated at 72.9% (35/48).
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| Recommendations for Labeling Changes |
Labeling should be updated with the results of the study at all evaluation follow-up times in the context of physician and patient.
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