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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020014 / PAS001 |
| Date Original Protocol Accepted |
11/04/2002
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| Date Current Protocol Accepted |
11/04/2002
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| Study Name |
Newly Trained Physicians
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| Device Name |
ESSURE SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study was designed to document the bilateral placement rate at first attempt for newly trained physicians in the U.S. These data were used to evaluate the training procedures and to update labeling.
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| Study Population |
Study population as per device indication . This device is indicated for permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes in adult women seeking permanent birth control.
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| Sample Size |
The study was originally designed to enroll 800 women from 40 physicians in the commercial setting.
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| Key Study Endpoints |
Data collected included: (1) successful bilateral placement rate at first attempt, and (2) identification of factors predictive of failure to achieve bilateral placement at first attempt.
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| Follow-up Visits and Length of Follow-up |
No patient follow-up was conducted as part of this study, with the exception of the follow-up data of the HSGs performed to evaluate the reasons for placement failure in women who desired a second attempt of device placement.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
After reviewing the final report, the Agency considered the conditions of approval for this study to be satisfied, with 514 women enrolled.
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| Actual Number of Sites Enrolled |
39
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| Patient Follow-up Rate |
N/A
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| Final Safety Findings |
Safety: There were 38 malfunctions in 27 cases, in 9 the distal tip was bent, the sponsor does not consider these are malfunctions. There were no reports of adverse events related to bent tips. There were 29 device malfunctions that included detachment problems, deployment issues, thumbwheel retraction difficulty, inner sleeve detachment and failure of delivery catheter to retract.
Placement rate: There were 13 adverse events that included perforation, pelvic pain, bleeding, light headed, increased blood pressure and temporary decreased pulse.
There were 476 women in whom bilateral placement was possible. After excluding all confounding, bilateral placement was achieved in 458 women for 96.2% (458/476) success rate. Bilateral failure happened in 10 women for 2.1% failure rate (10/476). After original approval of Essure system a new coil catheter was approved. The sponsor did a comparison of success rate by design. After excluding all confounding there were 184 procedures with the original model (gamma) and 297 procedures with the new model (coil catheter design). The new model performed better than the old, with a 96.0% success rate for the new coil catheter and 94.0% for the gamma model. Additionally, bilateral failure was less frequent with the new model (1.3% vs. 3.3%). The gamma model was discontinued in September 2003.
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| Study Strengths & Weaknesses |
Study provided precise estimate of bilateral placement at first attempt among newly trained physicians. Although the sponsor did not enroll the required number of women as per protocol, they were able to demonstrate with Bayesian statistics, that the observed rate was not diffderent from the rate observed in experienced physcians.
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| Recommendations for Labeling Changes |
Update label to include results from the PAS(bilaeral placement rate from newly trained physicians). Labeling should include the information on the number of patients excluded and why these patients were excluded from the post-approval study.
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020014 / PAS002 |
| Date Original Protocol Accepted |
11/04/2002
|
| Date Current Protocol Accepted |
11/04/2002
|
| Study Name |
5 year follow up
|
| Device Name |
ESSURE SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Extended follow-up (5 years) of premarket study cohorts: The Phase II Study and the Pivotal Study (formerly known as STOP).
The Phase II Study was a prospective, multi-center, international study of women seeking permanent birth control. There were sites in the US, Australia, Belgium, and Spain.
The Pivotal Trial was designed as a multi-center, non-randomized, single-arm, international study of women seeking permanent contraception. The study was conducted in the U.S., Europe, and Australia.
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| Study Population |
Adult women seeking permanent birth control. The study included participants of the premarket cohorts (Phase II and Pivotal Trial), ages 21 to 45 years old.
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| Sample Size |
Phase II Study: 269 women enrolled
Pivotal Trial: 657 women enrolled
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| Key Study Endpoints |
Phase II Study: Study primary objectives were to evaluate: Essure micro-insert placement rate, woman¿s tolerance and recovery from the micro-insert procedure, safety of the micro-insert procedure, woman¿s tolerance of the implanted micro-inserts, long-term safety of the implanted micro-inserts, and effectiveness of the micro-inserts in preventing pregnancies.
Pivotal Trial: Primary study endpoints: prevention of pregnancy, safety of the micro-insert placement procedure, and safety of the micro-insert wearing. Secondary endpoints included: participant satisfaction with the micro-insert placement procedure, participant satisfaction with micro-insert wearing, bilateral micro-insert placement rate; and development of a profile for an appropriate candidate for the Essure procedure.
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| Follow-up Visits and Length of Follow-up |
For both studies, women were followed at: 1 week-post device placement (PDP), 3 months PDP, 3, 6, and 12 months post-alternate contraception (PAC); and yearly through 5 years, as part of the post-approval study.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Phase II Study: 269 women enrolled from which, 227 underwent a micro-insert placement procedure. The remaining 42 women voluntarily withdrew, were excluded at the time of screening, or were enrolled into the Pivotal trial instead. There were 2 sites in the US (44 women), 1 site in Australia (130 women), 1 site in Belgium (28 women) and 1 site in Spain (25 women).
Pivotal Trial: A total of 657 women were enrolled in the study; of those, 518 underwent the Essure procedure and 453 women achieved bilateral occlusion 3 months post-procedure (4 unilateral placements). These 453 include 6 women that were followed for safety only.
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| Actual Number of Sites Enrolled |
Phase II Study: 5 sites
Pivotal Trial: 13 sites
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| Patient Follow-up Rate |
Phase II Study: 86.3% at 1-year; 85.5% at 2-year; 80.2% at 3-year; 77.5% at 4-year; 75.3% at 5-year.
Pivotal Trial: 97.5% at 1-year; 92.0% at 2-year; 89.4% at 3-year;85.2 at 4-year; 81.6% at 5-year
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| Final Safety Findings |
Phase II Study: Long-term Safety: Adverse events after the day of the procedure occurred in 9% of the women; 5% of these events were related to period pain, and ovulatory pain or changes in menstrual function. The other adverse events included: perforations (7), expulsion (1), unsatisfactory device location (1), and a retained micro-insert fragment (1). The perforations accounted for 3% of the patients that underwent the procedure. Four perforations were identified at the 3-month post-procedure evaluation; one was identified at the 18-month post-procedure evaluation. One additional case was of a peritubal perforation noted on gross examination following device removal due to pain. A seventh case was discovered when the woman had laparoscopic hysterectomy, the right device had perforated the tube. Six of the seven women that suffered perforations had the micro-insert located in the peritoneal cavity. In four of these women the device was removed successfully, in one woman the device was left in the peritoneal cavity. For the case of a retained micro-insert fragment, the event occurred during an attempt to remove the device that resulted in the broken distal ball tip. At the time of final report submission, there have been no reports of clinical sequelae for this case.
Pivotal Trial: Adverse events that initially prevented reliance by the woman on Essure occurred in 21 (4.5%) women. These were primarily Micro-insert expulsions following original Micro-insert placement that was out-of-specification. Nine of the women who experienced an expulsion chose to undergo a second placement procedure, and all were successful. Therefore, adverse events that ultimately prevented reliance occurred in only 12 women (2.6%). The most frequently reported adverse events reported in the first year that did not prevent the woman from relying on Essure, but were rated by the Investigator as at least "possibly" related to Essure, were back pain (6.2/1000 women-months), abdominal pain/cramps (2.6/1000) and dyspareunia (2.5/1000 women-months). All other events occurred at less than 2.5/1000 women-months of wearing.
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| Final Effect Findings |
In both studies, no pregnancies were reported while relying on Essure for contraception.
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| Study Strengths & Weaknesses |
The studies were limited in that there were no comparison groups. Both were designed to provide the pregnancy rate with the precision around it (95% Confidence Interval). Another limitation is the length of follow-up. Both studies were designed to provide an estimate of pregnancy rate out to 5 years; after which point there is no precise data on effectiveness and safety of the device, from these two studies. One of the strengths of the studies is the observed follow-up rates. The study provides a precise estimate of the pregnancy rate at 5 years
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| Recommendations for Labeling Changes |
Yes, label was updated to include the 5-year performance data
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