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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020014 S017/ PAS001 |
| Date Original Protocol Accepted |
02/24/2012
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| Date Current Protocol Accepted |
09/29/2016
|
| Study Name |
Essure/post-NovaSure PAS
|
| Device Name |
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
|
| 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
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Single-arm multi-center prospective observational study
|
| Study Population |
Women aged 21-50 with Essure micro inserts properly placed (confirmatory hysterosalpingogram) seeking treatment for menorrhagia.
|
| Sample Size |
A minimum of 220 female subjects relying on Essure micro- inserts seeking treatment for menorrhagia (i.e. NovaSure) at up to 30 US sites.
|
| Key Study Endpoints |
Primary: Occurrence of confirmed pregnancy at 1 year and 3 years among subjects relying on Essure micro-inserts for permanent birth control when NovaSure is performed.
Secondary: Incidence of adverse events (AEs) and/or complications associated with the performance of NovaSure in the presence of Essure micro-inserts, reported during follow-up visits.
|
| Follow-up Visits and Length of Follow-up |
3 years
One week post NovaSure procedure, then one, two, and three year post-endometrial ablation Phone Call
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
220 women with successful bilateral Essure insert location and tubal occlusion were enrolled, from which 215 met all the eligibility criteria. Among the 215 eligible women, 211 women had NovaSure attempted, and 209 women underwent the NovaSure endometrial ablation treatment. Out of all enrolled women (n=220), 11 women exited the study prior to a NovaSure treatment attempt (n=4), after NovaSure was attempted but before undergoing treatment (n=2) or were screening failures (n=5).
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| Actual Number of Sites Enrolled |
25 sites were included in the study. Subjects were enrolled from 18 sites.
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| Patient Follow-up Rate |
Out of all enrolled patients (220 women), 174 women completed the study (79.1%). Out of the women who underwent a NovaSure treatment, 83.3% (174/209) completed the study. There were 35 women who discontinued from the study and 11 lost to follow-up. For each post-endometrial ablation visit, out of all eligible women (n=215), the follow-up rates were:
1-week: 97.2%
1-year: 92.6%
2-year: 86.5%
3-year: 81.4%
|
| Final Safety Findings |
There were 211 women who had NovaSure attempted and make up the primary safety analysis cohort.
A total of 398 events were reported in 116/211 subjects (55.0%) from the primary safety cohort. There were 28 serious adverse events (SAEs) in 18 subjects and 370 non-serious adverse events in 113 subjects.
The AEs occurring in greater than or equal to 2% of subjects were pelvic pain (28 subjects, 13.3%); vaginal discharge (15 subjects, 7.1%); urinary tract infection (12 subjects, 5.7%); vaginal hemorrhage (10 subjects, 4.7%); heavy menstrual bleeding, dysmenorrhea, and nausea (9 subjects, 4.3% each); abdominal pain (7 subjects, 3.3%); procedural pain and uterine spasm (6 subjects, 2.8% each); and fatigue, uterine hemorrhage, and vulvovaginal pruritus (5 subjects, 2.4% each).
SAEs are a subset of all the reported AEs. The SAEs occurring in more than 2 subjects were pelvic pain (5 subjects, 2.4%) and heavy menstrual bleeding (2 subjects, 0.9%). One (n=1) subject (0.5%) died due to congestive cardiac failure; the death was assessed as not related to the Essure device, NovaSure device, or NovaSure procedure.
None of these events represent unanticipated adverse device effects and the events are consistent with available data for Essure and NovaSure.
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| Final Effect Findings |
No pregnancies were reported at any timepoint in the study. The 95% upper Bayesian credible interval was 1.23% and 1.33% at 1 year and 3 years, respectively, which meets the predetermined study success threshold of 2.1% and 2.8% at 1 year and 3 years, respectively.
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| Study Strengths & Weaknesses |
The study was designed to provide the pregnancy rate in women with successful bilateral Essure insert location and tubal occlusion who underwent NovaSure endometrial ablation treatment, with a confidence interval of 95%. One strength of the study is the high observed follow-up rate. A limitation of the study is the data collection through phone call follow-up visits, instead of a clinical exam.
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| Recommendations for Labeling Changes |
Not applicable. On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. As of December 31, 2019, all unused Essure units should have been returned to Bayer so that they are no longer available for implantation. The most recent labeling from 2018 includes warning and precautions about performing endometrial ablation of the uterus in patients with Essure inserts.
The most recent labeling indicates that investigations are ongoing to understand contraception rates in women with successful bilateral Essure insert location and tubal occlusion who underwent NovaSure endometrial ablation treatment. This post-approval study provides information on the subject population described above. In this post-approval study, the self-reported pregnancy rate among study participants relying on Essure micro-inserts for permanent birth control when NovaSure was performed was 0% at 1 year and 0% at 3 years. These post-approval study findings support the information already included in the labeling.
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