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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020014 S012/ PAS001 |
| Date Original Protocol Accepted |
06/15/2007
|
| Date Current Protocol Accepted |
06/15/2007
|
| Study Name |
ESS-305
|
| Device Name |
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
|
| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
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| 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 |
This is an observational cohort study. A new cohort of patients and physicians will be enrolled to collect procedural data on ESS305. Data from the Study for Newly Trained Physicians (completed September 2005) will be used as the comparator. The protocol also includes collection of adverse events data.The purpose of this post-approval clinical study is to determine the following: 1. Bilateral placement ofthe ESS305 micro-insert at first attempt; 2. Comparison of bilateral placement success between NewlyTrained physicians and Experienced physicians
3. Identification of factors predictive of failure to achieve bilateral placement ofthe ESS305 micro-insert al first attempt; 4. Evaluation of aspects ofthe ESS305 design that may impact
bilateral placement rate; 5. Hysteroscopy time to perform the procedure 6. Adverse device effects; and 7. Adverse procedure events.
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| Study Population |
Study population is 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 |
657 women enrolled - protocol states 20 sites enrolled patients
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| Key Study Endpoints |
Study endpoints include: (1) bilateral micro-insert placement rate, (2) identification of factors predictive of micro-insert placement failure, (3) evaluation of aspects of the ESS305 design that may impact bilateral placement rate; and (4) hysteroscopy time to perform the procedure.
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| Follow-up Visits and Length of Follow-up |
N/A
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
584 women
|
| Actual Number of Sites Enrolled |
76
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| Patient Follow-up Rate |
81.60%
|
| Final Safety Findings |
The sponsor reported only 6 adverse events occurred during and after the Essure placement procedure (6 out of 584). All reported events were minor with the exception of one case. The subject was hospitalized after hysteroscopy resulted in a uterine perforation by the hysteroscope. The sponsor claims the Essure device did not cause the injury to the patient. None of these events represent unanticipated adverse device effects.
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| Study Strengths & Weaknesses |
The study is well designed to evaluate the placement rate among newly trained physicians at first attempt, when implanting the device in women seeking permanent sterilization.
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| Recommendations for Labeling Changes |
Update labeling with the results of the study in the context of patient and physician labeling.
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