Observational Study on Contraception With Essure in France

Completed

• Conditions: Contraception
• Interventions: Device: ESS305 (Essure, BAY1454032)

• Registration Number: NCT02510443
• Lead Sponsor: Bayer

Brief Summary

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

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

Study Timeline

• Study Start: 2008-06-23
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Primary Completion: 2016-09-29
• Study Completion: 2016-11-25
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2644

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.

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Exclusion Criteria

• Patients with contraindications as listed in the current Instruction For Use (IFU) will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY1454032	ESS305 (Essure, BAY1454032)	All subjects who give their consent and meet the eligibility criteria will be scheduled for an insert placement procedure

Primary Outcome Measures

Name	Time	Method
Number of patients being satisfied with successful Essure procedure having no complications at 5 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of unsatisfied patients	Up to 5 years
Number of patients with moderate or important pain when placement is performed	At initial visit	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.
Number of examinations by patients	At 3 months
Type of examinations by patients	At 3 months	Ultrasound transvaginale, radiography, or hysterosalpingography (HSG)
Number of satisfied patients at 3, 12 and 24 months	At 3 ,12 and 24 months	Patients satisfaction assessed by Likert scale.
Causes of unsatisfied patients	Up to 5 years	Possible causes of unsatisfaction : pregnancy, regret of the patient,migration/expulsion of Essure,or infection
Number of patients with regrets	At 12 months, 24 months and 5 years
Number of good insert position by implant and patients with success in final result of the procedure	At 3 months