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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010013 S041/ PAS001 |
| Date Original Protocol Accepted |
02/01/2013
|
| Date Current Protocol Accepted |
01/04/2022
|
| Study Name |
NovaSure PAS
|
| Device Name |
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
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| 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 B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, single-arm, multi-center study
|
| Study Population |
Premenopausal women greater than or equal to 18 years old with menorrhagia due to benign causes for whom childbearing is complete and have received an Essure Permanent Birth Control System
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| Sample Size |
Up to 21 sites, 318 patients
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| Key Study Endpoints |
1. Primary Endpoint: Removal of an Essure micro-insert with the NovaSure device
2. Secondary Endpoints:
2.1. AEs during and/or immediately following the NovaSure procedure;
2.2. AEs up to 1 month after the NovaSure procedure
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| Follow-up Visits and Length of Follow-up |
1 Month
1 Follow-up assessment
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
16
|
| Actual Number of Sites Enrolled |
16
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| Patient Follow-up Rate |
Out of all enrolled patients (148), 127 patients completed the study (85.8%). Out of the women who underwent a NovaSure treatment, 95.4% (127/133) completed the study. There were 15 patients who were screened after enrollment and 6 lost to follow-up.
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| Final Safety Findings |
Note: The original study enrolled 127 patients that underwent NovaSure post Essure placement and completed the study. Data from the original study was supplemented with data from Bayer Pharma AG’s study (P020014/S017/PAS001) with a comparable patient population. Supplemental data provided from the Bayer study included 211 treated patients, bringing the total number of patients evaluated with these two data sets (Hologic and Bayer) to 338. Please see the P020014/S017/PAS001 database for more details. Outcomes below are broken down by study.
Removal of Essure Inserts with NovaSure Device:
There were no inadvertent removals of an Essure micro-insert due to snagging on the NovaSure array in both Hologic’s and Bayer’s studies.
AEs During and/or Immediately following NovaSure Procedure and up to 1 Month following the Procedure:
Hologic Study
A total of 102 events were reported in 48/127 subjects (37.8 %). There were 0 serious adverse events (SAEs). Among 102 adverse events (AEs), 72 events were during and/or immediately following the NovaSure procedure and 30 events were up to 1 month after the NovaSure procedure.
The AEs occurring in greater than or equal to 2% of subjects were uterine spasm (28 subjects, 22.0%); vaginal hemorrhage (24 subjects, 18.9%); vaginal discharge (19 subjects, 15.0%); abdominal pain (6 subjects, 4.7%); nausea (3 subjects, 2.4%); and vomiting (3 subjects, 2.4%).
Bayer Study
Data from the Bayer study did not distinguish between events immediately after the procedure or up to 1 month following, as initial follow up was recorded at 1 month. A total of 94 events were reported in 53/211 subjects (25.1 %) within 1 month from the NovaSure procedure. There were 4 SAEs in 3/211 subjects within 1 month from the NovaSure procedure.
The AEs occurring in greater than or equal to 2% of subjects were vaginal discharge (12 subjects, 5.7%); pelvic pain (9 subjects, 4.3%); vaginal hemorrhage (8 subjects, 3.8%); uterine spasm (6 subjects, 2.8%); abdominal pain (6 subjects, 2.8%); nausea (6 subjects, 2.8%); and procedural pain (5 subjects, 2.4%).
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| Final Effect Findings |
There were no key endpoints related to the effectiveness of the NovaSure device.
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| Study Strengths & Weaknesses |
The study enrollment did not meet original sample size (318). While supplemental data were provided from the Bayer study which had a similar patient population, there were differences in protocol between the two studies that may impact poolability (e.g., initial follow up timepoint, primary endpoint). Therefore, caution should be taken with interpretation of the combined results.
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| Recommendations for Labeling Changes |
None, the NovaSure labeling approved in S041 that required this PAS already includes information regarding potential thermal injury following ablation in patients with Essure inserts.
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