Observational Study on Contraception With Essure in France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2644 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-23

Study Completion Date

2016-11-25

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.

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Detailed Description

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

Conditions

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Contraception

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BAY1454032

All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure

ESS305 (Essure, BAY1454032)

Intervention Type DEVICE

Bilateral insert placement

Interventions

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ESS305 (Essure, BAY1454032)

Bilateral insert placement

Intervention Type DEVICE

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.