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| ID | Type | Description | Link |
|---|---|---|---|
| ES0810FR | Other Identifier | Company Internal |
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| Name | Class |
|---|---|
| Hôpital André Mignot Centre Hospitalier de Versailles | UNKNOWN |
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Using a very broad survey, the objective is to confirm the effectiveness of the Essure method, and to obtain more information on the conditions of use as well as on the methods used during the 3-month check-up, as well as the 12-month, 24-month and 5-year follow-up on patients.
The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1454032 | All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESS305 (Essure, BAY1454032) | Device | Bilateral insert placement |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients being satisfied with successful Essure procedure having no complications at 5 years | Patient satisfaction will be assessed on a Likert scale. Complications are migration/expulsion of Essure, infection. Pregnancy will be measured at any time Point. | At 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with moderate or important pain when placement is performed | Visual Analogue Scale (VAS) use to report the pain from 0 (no pain) to 10 (maximal pain). Moderate pain will range from 4 to 6 and important pain will range from 7 to 10 on the VAS. | At initial visit |
| Number of unsatisfied patients |
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Inclusion Criteria:
Exclusion Criteria:
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The patients concerned are adult women wishing to undergo tubal sterilization for contraceptive purposes, in accordance with legal provisions, who had given their consent for collection of the data.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Chesnay | 78150 | France |
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| Up to 5 years |
| Number of satisfied patients at 3, 12 and 24 months | Patients satisfaction assessed by Likert scale. | At 3 ,12 and 24 months |
| Number of examinations by patients | At 3 months |
| Number of good insert position by implant and patients with success in final result of the procedure | At 3 months |
| Causes of unsatisfied patients | Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection | Up to 5 years |
| Type of examinations by patients | Ultrasound transvaginale, radiography, or hysterosalpingography (HSG) | At 3 months |
| Number of patients with regrets | At 12 months, 24 months and 5 years |