Observational Study on Contraception With Essure in France

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a prospective epidemiological survey to collect local real life data on patients under routine pratice

Official Title
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Survey on Use and Characteristics of Definitive Contraception With ESsure®

Conditions
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Contraception

Intervention / Treatment
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* Device: ESS305 (Essure, BAY1454032)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman ≥ 18 years old, Scheduled for Essure procedure Patient who has been given appropriate information about the study objectives and procedures and who has given her consent. Exclusion Criteria: Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAY1454032<br>All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure | Device: ESS305 (Essure, BAY1454032)<br>* Bilateral insert placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Permanent contraception method, Contraceptive device